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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020493-42 | EudraCT Number |
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The study was terminated based on new efficacy data from another study.
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The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.
The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine -open label treatment period | Experimental | Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily. Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events. |
|
| Vortioxetine -double-blind relapse prevention period | Experimental | Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily. In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period |
|
| Placebo -double-blind relapse prevention period | Placebo Comparator | Placebo - encapsulated tablets, orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse in the Double-blind Period | Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). | From randomization to Week 26 in the double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse | Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). |
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Inclusion Criteria:
De novo participants
Exclusion Criteria:
Other 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 |
|---|---|---|---|---|---|---|
| Alliance for Research | Long Beach | California | 90807 | United States | ||
| Atlanta Center for Medical Research |
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Rollover participants from Study 12709A enrolled to the open-label period and rollover participants (remitters) from Study 12712A randomized to the double-blind period. Overall, 35 participants were treated in this study: 33 participants in the open-label period (24 de novo participants and 9 rollover participants from Study 12709A) and 4 participants in the double-blind period (2 of whom rolled-over from Study 12712A).
The study population included de novo participants as well as rollover participants from other paediatric vortioxetine studies (Studies 12709A [NCT02709655] and 12712A [NCT02871297]) who, in the investigator's opinion, would benefit from continued treatment with vortioxetine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Treatment: Vortioxetine | Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed. |
| FG001 | Double-Blind Relapse Prevention: Vortioxetine | Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period. |
| FG002 | Double-Blind Relapse Prevention: Placebo | Participants received placebo for 26 weeks in the double-blind relapse prevention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-Label (12 Weeks) |
|
| ||||||||||||||||||||||||
| Double-Blind (26 Weeks) |
|
All-patients-enrolled (APES): all participants enrolled to the 12-week open-label treatment period who took at least 1 dose of study drug. Full analysis set (FAS): all participants randomized to the 26-week double-blind treatment period who took at least 1 dose of double-blind study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label Treatment: Vortioxetine | Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Data are being reported separately for the open-label and double-blind arms. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Relapse in the Double-blind Period | Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | From randomization to Week 26 in the double-blind treatment period |
|
Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label Treatment: Vortioxetine | Participants initiated treatment with vortioxetine tablets 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food poisoning | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@Lundbeck.com |
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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 | Jan 7, 2021 | Oct 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2021 | Dec 12, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Tablets |
|
| From randomization to Week 26 in the double-blind treatment period |
| Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26 | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). | Baseline, Week 26 |
| Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26 | 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 26 |
| Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26 | 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). | Week 26 |
| Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26 | The PQ-LES-Q is a participant-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 participants 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 26 |
| Plasma Concentration of Vortioxetine | From randomization to Week 26 in the double-blind treatment period |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| AIM Trials, LLC | Plano | Texas | 75093 | United States |
| 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 | 660001 | Colombia |
| Linda Keruze's Psychiatric Center, LLC | Liepāja | 3401 | Latvia |
| CRI Centro Regiomontano de Investigacion SC | Monterrey | Nuevo León | 64060 | Mexico |
| BIND Investigaciones S.C | San Luis Potosí City | San Luis Potosí | 78213 | Mexico |
| SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C | Culiacan de Rosales | Sinaloa | 80230 | Mexico |
| Przychodnia Syntonia Izabela Chojnowska-Cwiakala | Kielce | 25-103 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska | Poznan | 60744 | Poland |
| Medicorehabilitation Research Center Phoenix | Rostov-on-Don | Rostov State | 344010 | Russia |
| GUZ Engels Psychiatric Hospital | Engel's | 413124 | Russia |
| Rostov State Medical University of the Minzdravsotsrazvitiya of Russia | Rostov-on-Don | 344002 | Russia |
| Nebbiolo LLC | Tomsk | 634009 | Russia |
| Odessa Regional Psychiatry Hospital No. 2 | Odesa | 65128 | Ukraine |
| Withdrawal by Subject |
|
| Based on Sponsor Information of Results From Vortioxetine Study |
|
| Sponsor Decision |
|
| Study Terminated by Sponsor |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Double-Blind Relapse Prevention: Vortioxetine | Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period. |
| BG002 | Double-Blind Relapse Prevention: Placebo | Participants received placebo for 26 weeks in the double-blind relapse prevention period. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Data are being reported separately for the open-label and double-blind arms. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data are being reported separately for the open-label and double-blind arms. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data are being reported separately for the open-label and double-blind arms. | Count of Participants | Participants |
|
| OG000 | Double-Blind Relapse Prevention: Vortioxetine | Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period. |
| OG001 | Double-Blind Relapse Prevention: Placebo | Participants received placebo for 26 weeks in the double-blind relapse prevention period. |
|
| Secondary | Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse | Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | From randomization to Week 26 in the double-blind treatment period |
|
|
| Secondary | Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26 | The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | Baseline, Week 26 |
|
|
| Secondary | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26 | 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). | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | Baseline, Week 26 |
|
|
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26 | 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). | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | Week 26 |
|
|
| Secondary | Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26 | The PQ-LES-Q is a participant-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 participants 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. | Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure. | Posted | Baseline, Week 26 |
|
|
| Secondary | Plasma Concentration of Vortioxetine | Due to early termination of the study, the pharmacokinetic analyses were not performed and the data were not collected. | Posted | From randomization to Week 26 in the double-blind treatment period |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 8 |
| 33 |
| EG001 | Double-Blind Relapse Prevention: Placebo | Participants received placebo for 26 weeks in the double-blind relapse prevention period. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Double-Blind Relapse Prevention: Vortioxetine | Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period. | 0 | 2 | 0 | 2 | 0 | 2 |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
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Not provided
| Adolescents (12-17 years) |
|
| Title | Measurements |
|---|---|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Male |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Title | Measurements |
|---|---|
| White |
|
| Black or African American |
|
| Asian |
|
| Other |
|