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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005353-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10 mg/day | Experimental |
| |
| Vortioxetine 20 mg/day | Experimental |
| |
| Fluoxetine 20 mg/day, | Active Comparator | A decision has been taken to stop recruitment into this treatment arm. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10 mg/day | Drug | 10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach. | Baseline (Week 4 of Phase A), Week 8 of Phase B |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| Sun Valley Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40922774 | Derived | Huss M, Findling RL, DelBello MP, Necking O, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study. JAACAP Open. 2024 Nov 22;3(3):736-748. doi: 10.1016/j.jaacop.2024.11.002. eCollection 2025 Sep. |
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Participants who demonstrated an incomplete improvement in depressive symptoms at the end of the SB period (Week 4) entered the DB period to receive BPI (2 sessions) and treatment as follows: Prior to the interim analysis, participants were randomized in a 1:1:1:1 ratio to placebo, vortioxetine 10 mg/day, vortioxetine 20 mg/day, or fluoxetine 20 mg/day. After interim analysis, participants were randomized in a 1:1:1 ratio to placebo, vortioxetine 10 mg/day, or vortioxetine 20 mg/day.
This study included 2 periods: single-blind (SB) (treatment with standardized brief psychosocial intervention [BPI] and placebo) and double-blind (DB) (treatment with BPI and placebo, vortioxetine 10 milligrams [mg]/day, vortioxetine 20 mg/day, or fluoxetine 20 mg/day).
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Blind: Placebo | Participants received BPI (3 sessions) and placebo capsules orally once daily for 4 weeks. |
| FG001 | Double-Blind: Placebo | Participants received placebo capsules orally once daily for 8 weeks. Participants received 2 sessions of BPI also. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single-Blind Phase (4 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 21, 2018 | Jul 15, 2022 |
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|
| Vortioxetine 20 mg/day | Drug | 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed |
|
|
| Fluoxetine 20mg/day | Drug | 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed |
|
| Placebo | Other | Encapsulated tablet, orally |
|
| Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B |
| Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B | The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Four subscores were defined based on the CDRS-R: Mood: sum of items 8, 11, 14, 15; score range 4 to 28, Somatic: sum of items 4, 5, 6, 7, 16, 17; score range 6 to 36, Subjective: sum of items 9, 10, 12, 13; score range 4 to 28, and Behaviour: sum of items 1, 2, 3; score range 3 to 21. Higher scores indicated the most severe measure of depression. | Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B |
| Percentage of Participants With CDRS-R Response | CDRS-R response was defined as a ≥50% decrease in CDRS-R total score, calculated as: (change from baseline [Randomization])/(baseline value - 17). The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | Weeks 2, 4, 6, and 8 of Phase B |
| Percentage of Participants With CDRS-R Remission | CDRS-R remission was defined as a CDRS-R total score ≤28. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | Weeks 2, 4, 6, and 8 of Phase B |
| Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B | The GBI 10-item depression scale was developed to screen for depressive symptoms in children and adolescents. Two versions of the GBI 10-item depression scale were used, the child rated version (CGBI) and the parent rated version (PGBI). The 10 depression items were rated on a 4-point scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranged from 0 to 30, with higher scores indicating greater pathology. | Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B |
| Parent Global Assessment (PGA) Score | The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of symptoms using a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Weeks 2, 4, 6, and 8 of Phase B |
| Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B | The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). | Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
| Clinical Global Impression - Global Improvement (CGI-I) Score | The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
| Percentage of Participants With CGI-S Remission | CGI-S remission was defined as a CGI-S score of 1 or 2. The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). | Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
| Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B | The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B | The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction. | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B | The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarize their experience in a global rating. Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good). | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
| Imperial |
| California |
| 92251 |
| United States |
| Synergy Clinical Research Center | Lemon Grove | California | 91945 | United States |
| Alliance for Wellness dba Alliance for Research | Long Beach | California | 90807 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Asclepes Research Center | Panorama City | California | 91402 | United States |
| Children's National Medical Center Merge | Washington D.C. | District of Columbia | 20010 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| American Medical Research, Inc. | Chicago | Illinois | 60612 | United States |
| AMR- Baber Research, Inc. | Naperville | Illinois | 60563 | United States |
| AMR Conventions Research | Warrenville | Illinois | 60555 | United States |
| Kansas University School of Medicine-Wichita | Wichita | Kansas | 67214 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Millennium Psychiatric Associates, LLC | St Louis | Missouri | 63132 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10036 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry | Cleveland | Ohio | 44012 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | United States |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | United States |
| Research Strategies Of Memphis, Llc | Memphis | Tennessee | 38119 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| AIM Trials, LLC | Plano | Texas | 75093 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Westside Medical | Clinton | Utah | 84015 | United States |
| Aspen Clinical Research, LLC | Orem | Utah | 84058 | United States |
| MHAT Targovishte AD | Targovisthe | 7700 | Bulgaria |
| Diagnostic Consultative Center Mladost-M Varna OOD | Varna | 9020 | Bulgaria |
| Paediatric Sleep Research Inc. | Toronto | Ontario | M5S 3A3 | Canada |
| E.S.E. Hospital Mental de Antioquia HOMO | Bello | Antioquia | 51050 | Colombia |
| Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS. | Barranquilla | Atlántico | 80020 | Colombia |
| Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS | Bogotá | DC | 111166 | Colombia |
| Psynapsis Salud Mental S.A. | Pereira | Risaralda Department | Colombia |
| Marienthali Kliinik | Tallinn | 11315 | Estonia |
| Cabinet Psyche | Douai | Nord | 59500 | France |
| Centre Medical Ambroise Pare | Élancourt | 78990 | France |
| CHU de Nantes - Hopital Hotel Dieu | Nantes | 44093 | France |
| Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri | Mainz | 55122 | Germany |
| Vadaskert Alapitvany | Budapest | 1021 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula | 5700 | Hungary |
| Shalvata Mental Health Center | Hod HaSharon | 4534708 | Israel |
| Ramat Chen - Mental Health Clinic | Tel Aviv | 6435807 | Israel |
| The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital | Tel Litwinsky | 5262000 | Israel |
| Scientific Institute Fondazione Stella Maris | Calambrone Pisa | Pisa | 56026 | Italy |
| Sciaf Ulss 16 Padova | Padova | Regione Veneto | 35143 | Italy |
| University Federico II Of Naples | Naples | 80131 | Italy |
| Linda Keruze's Psychiatric Center, LLC | Liepāja | LV-3401 | Latvia |
| Children Hospilal -Gailezers | Riga | 1079 | Latvia |
| Centro Investigacion Medico Biologica Y Terapia Avanzada | Guadalajara | Jalisco | 44130 | Mexico |
| Clinica Cemelli | Guadalajara | Jalisco | 44200 | Mexico |
| Roberto Zepeda Sanchez | Guadalajara | Jalisco | 44690 | Mexico |
| Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) | Mexico City | Mexico City | 04530 | Mexico |
| CRI Centro Regiomontano de Investigacion SC | Monterrey | Nuevo León | 64060 | Mexico |
| Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C | Culiacan de Rosales | Sinaloa | 80230 | Mexico |
| B & B Investigaciones Medicas, SC | Mazatlán | Sinaloa | 82140 | Mexico |
| ICARO Investigaciones en Medicina S.A. de C.V. | Chihuahua City | 31000 | Mexico |
| BIND Investigaciones S.C | San Luis Potosí City | 78213 | Mexico |
| Prywatne Gabinety Lekarskie Promedicus | Bialystok | Podlaskie Voivodeship | 15879 | Poland |
| Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| Przychodnia Syntonia Poradnia Zdrowia Psychicznego | Kielce | 25-103 | Poland |
| Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny | Lublin | 20-884 | Poland |
| Filip Rybakowski Specjalistyczna Praktyka Lekarska | Poznan | 60-744 | Poland |
| Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu | Wałbrzych | 58300 | Poland |
| Medicorehabilitation Research Center Phoenix | Rostov-on-Don | Rostov State | 344010 | Russia |
| Stavropol Region Psychiatric Hospital No.2 | Stavropol | Stavropol Kray | 357034 | Russia |
| Arkhangelsk Regional Clinical Mental Hospital | Arkhangelsk | 163530 | Russia |
| GUZ Engels Psychiatric Hospital | Engel's | 413124 | Russia |
| State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ... | Krasnodar | 350007 | Russia |
| LLC City Neurological Center Sibneuromed | Novosibirsk | 630091 | Russia |
| Rostov State Medical University of the Minzdravsotsrazvitiya of Russia | Rostov-on-Don | 344022 | Russia |
| City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov | Saint Petersburg | 197341 | Russia |
| Saratov State Medical University | Saratov | 410028 | Russia |
| Guz Saratov Regional Psychiatric Hospital St. Sofii | Saratov | 410060 | Russia |
| Nebbiolo LLC | Tomsk | 634009 | Russia |
| Yaroslavl Regional Clinical Psychiatry Hospital | Yaroslavl | 150003 | Russia |
| State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi... | Yekaterinburg | 620030 | Russia |
| Child and Adolescent Neurology and Psychiatry Clinic | Belgrade | 11000 | Serbia |
| Institute of Mental Health | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Clinical Center of Vojvodina - Clinic of Psychiatry | Novi Sad | 21000 | Serbia |
| Daily Hospital for Children and Adolescents | Pantelej-Nis | 18000 | Serbia |
| Cape Trial Centre | Bellville | Cape Town | 7530 | South Africa |
| Tara Hospital | Sandhurst | Gauteng | 2196 | South Africa |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo | Torremolinos | Malaga | 29620 | Spain |
| Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro... | Kyiv | 04080 | Ukraine |
| Odessa Regional Medical Centre of Mental Health | Odesa | 65006 | Ukraine |
| Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U... | Poltava | 36013 | Ukraine |
| Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers... | Ternopil | 46000 | Ukraine |
| FG002 | Double-Blind: Vortioxetine 10 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| FG003 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| FG004 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Phase (8 Weeks) |
|
|
All-patients-treated set Phase A (APTS_A) included all participants enrolled to the 4-week Single-blind period (Phase A) who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single-Blind: Placebo | Participants received BPI (3 sessions) and placebo capsules orally once daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Children Depression Rating Scale - Revised (CDRS-R) Total Score | The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | Baseline measure was taken for all participants randomized to Phase B. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach. | Full analysis set (FAS) included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Week 8 of Phase B |
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| Secondary | Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B |
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| Secondary | Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B | The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Four subscores were defined based on the CDRS-R: Mood: sum of items 8, 11, 14, 15; score range 4 to 28, Somatic: sum of items 4, 5, 6, 7, 16, 17; score range 6 to 36, Subjective: sum of items 9, 10, 12, 13; score range 4 to 28, and Behaviour: sum of items 1, 2, 3; score range 3 to 21. Higher scores indicated the most severe measure of depression. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable for specified categories. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B |
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| Secondary | Percentage of Participants With CDRS-R Response | CDRS-R response was defined as a ≥50% decrease in CDRS-R total score, calculated as: (change from baseline [Randomization])/(baseline value - 17). The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Number | percentage of participants | Weeks 2, 4, 6, and 8 of Phase B |
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| Secondary | Percentage of Participants With CDRS-R Remission | CDRS-R remission was defined as a CDRS-R total score ≤28. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Number | percentage of participants | Weeks 2, 4, 6, and 8 of Phase B |
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| Secondary | Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B | The GBI 10-item depression scale was developed to screen for depressive symptoms in children and adolescents. Two versions of the GBI 10-item depression scale were used, the child rated version (CGBI) and the parent rated version (PGBI). The 10 depression items were rated on a 4-point scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranged from 0 to 30, with higher scores indicating greater pathology. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable for specified categories. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B |
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| Secondary | Parent Global Assessment (PGA) Score | The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of symptoms using a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 2, 4, 6, and 8 of Phase B |
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| Secondary | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B | The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
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| Secondary | Clinical Global Impression - Global Improvement (CGI-I) Score | The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
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| Secondary | Percentage of Participants With CGI-S Remission | CGI-S remission was defined as a CGI-S score of 1 or 2. The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Number analyzed = participants evaluable at specified timepoint. | Posted | Number | percentage of participants | Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
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| Secondary | Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B | The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B | The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B | The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction. | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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| Secondary | Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B | The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarize their experience in a global rating. Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good). | FAS included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug and who had a valid baseline (Week 4 of Phase A) assessment and at least 1 valid post-baseline assessment of the CDRS-R total score. Overall number of participants analyzed = participants evaluated for this outcome measure. Number analyzed = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B |
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Baseline up to Week 16
All-patients-treated set Phase A (APTS_A) included all participants enrolled to the 4-week Single-blind period (Phase A) who received at least 1 dose of study drug. All-patients-treated set Phase B (APTS) included all participants randomized to the double-blind, 8-week treatment period (Phase B) who took at least 1 dose of double-blind study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Single-Blind: Placebo | Participants received BPI (3 sessions) and placebo capsules orally once daily for 4 weeks. | 0 | 677 | 6 | 677 | 106 | 677 |
| EG001 | Double-Blind: Placebo | Participants received placebo capsules orally once daily for 8 weeks. Participants received 2 sessions of BPI also. | 0 | 153 | 3 | 153 | 45 | 153 |
| EG002 | Double-Blind: Vortioxetine 10 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. | 0 | 151 | 1 | 151 | 55 | 151 |
| EG003 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. | 0 | 153 | 2 | 153 | 42 | 153 |
| EG004 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. | 0 | 83 | 1 | 83 | 27 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Viral pharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Tracheitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Illness | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@Lundbeck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2022 | Jul 15, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Lack of Efficacy |
|
| Non-compliance with study drug |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other than specified |
|
|
| Black or African American |
|
| Not Reported |
|
| Other |
|
| White |
|
| Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction. | Mixed Models Analysis | 0.2336 | Mean Difference (Final Values) | -1.72 | Standard Error of the Mean | 1.44 | 2-Sided | 95 | -4.56 | 1.11 | Other |
| Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction. | Mixed Models Analysis | 0.0879 | Mean Difference (Final Values) | -2.46 | Standard Error of the Mean | 1.44 | 2-Sided | 95 | -5.29 | 0.37 | Other |
| Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction. | Mixed Models Analysis | 0.0531 | Mean Difference (Final Values) | -3.30 | Standard Error of the Mean | 1.70 | 2-Sided | 95 | -6.65 | 0.04 | Other |
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also.
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG001 | Double-Blind: Vortioxetine 10 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also.
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| Double-Blind: Vortioxetine 20 mg |
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 |
| Double-Blind: Vortioxetine 20 mg |
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days and thereafter they received 10 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
|
|
| OG002 | Double-Blind: Vortioxetine 20 mg | Participants initiated treatment with vortioxetine capsules 5 mg/day orally for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days, and thereafter they received vortioxetine 20 mg/day for up to Week 8. Based on the tolerability, vortioxetine dose could be reduced by 5 mg/day at Week 4. Participants received 2 sessions of BPI also. |
| OG003 | Double-Blind: Fluoxetine 20 mg | Participants initiated treatment with fluoxetine 10 mg/day orally for 6 days and thereafter they received 20 mg/day. for up to Week 8. Based on the tolerability, fluoxetine dose could be reduced by 10 mg/day at Week 4. Participants received 2 sessions of BPI also. |
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