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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022257-41 | EudraCT Number | ||
| U1111-1117-6595 | Registry Identifier | WHO | |
| JapicCTI-101344 | Registry Identifier | JapicCTI | |
| CTRI/2011/08/001963 | Registry Identifier | CTRI |
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The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying doses of vortioxetine.
The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in 14 countries in Europe and Asia. The overall time to participate in this study was up to 13 weeks. Participants made weekly visits to the clinic during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to the end of the 8-week treatment period. Participants who completed the 8-week treatment period entered a 2-week discontinuation period to assess potential discontinuation symptoms 1 and 2 weeks after the end of the 8-week treatment period. A safety follow-up contact (visit or phone call) was made 4 weeks after completion of the 8-week double-blind treatment period (2 weeks after the end of the 2-week discontinuation period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. |
|
| Vortioxetine 5 mg | Experimental | Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
|
| Vortioxetine 10 mg | Experimental | Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
|
| Vortioxetine 20 mg | Experimental | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Vortioxetine tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a MADRS Response at Week 8 | Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
Has one or more of the following conditions:
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Split | Croatia | Croatia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36708956 | Derived | Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26. | |
| 28858412 | Derived |
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Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 5 mg, 10 mg, or 20 mg vortioxetine.
Participants took part in the study at 90 investigative sites in Japan, Europe and Asia/Oceania from 18 November 2010 to 25 April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. |
| FG001 | Vortioxetine 5 mg | Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Vortioxetine placebo-matching tablets |
|
| Baseline and Week 8 |
| Percentage of Participants in MADRS Remission at Week 8 | Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Week 8 |
| Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 | The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate. | Week 8 |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate. | Baseline and Week 8 |
| Zagreb |
| Croatia |
| Croatia |
| Helsinki | Finland | Finland |
| Kuopio | Finland | Finland |
| Oulu | Finland | Finland |
| Tampere | Finland | Finland |
| Berlin | Germany | Germany |
| Bochum | Germany | Germany |
| Chemnitz | Germany | Germany |
| Hanover | Germany | Germany |
| Leipzig | Germany | Germany |
| München | Germany | Germany |
| Nuremberg | Germany | Germany |
| Schwerin | Germany | Germany |
| Westerstede | Germany | Germany |
| Wiesbaden | Germany | Germany |
| Hong Kong | Hong Kong | Hong Kong |
| Hyderabad | Andhra Pradesh | India |
| Ahmedabad | Gujarat | India |
| Kanpur | Uttar Pradesh | India |
| Lucknow | Uttar Pradesh | India |
| Varanasi | Uttar Pradesh | India |
| Tokoname-shi | Aichi-ken | Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu-shi | Fukuoka | Japan |
| Omuta-shi | Fukuoka | Japan |
| Shirakawa-shi | Fukushima | Japan |
| Sapporo | Hokkaido | Japan |
| Yokohama | Kanagawa | Japan |
| Kumamoto | Kumamoto | Japan |
| Tokyo | Tokyo | Japan |
| Liepāja | Latvia | Latvia |
| Riga | Latvia | Latvia |
| Sigulda | Latvia | Latvia |
| Johor Bahru | Malaysia | Malaysia |
| Kuala Lumpur | Malaysia | Malaysia |
| Makati City | NCR | Philippines |
| Mandaluyong | NCR | Philippines |
| Manila | NCR | Philippines |
| Quezon City | NCR | Philippines |
| Bialystok | Poland | Poland |
| Gorlice | Poland | Poland |
| Leszno | Poland | Poland |
| Torun | Poland | Poland |
| Żuromin | Poland | Poland |
| Iași | Lasi | Romania |
| Târgu Mureş | Mureș County | Romania |
| Bucharest | Romania | Romania |
| Nizhny Novgorod | Russia | Russia |
| Rostov-on-Don | Russia | Russia |
| Saint Petersburg | Russia | Russia |
| Smolensk | Russia | Russia |
| Stavropol | Russia | Russia |
| Yekaterinburg | Russia | Russia |
| Belgrade | Serbia | Serbia |
| Kragujevac | Serbia | Serbia |
| Senta | Serbia | Serbia |
| Sungnam-si | Gyeonggi-do | South Korea |
| Incheon | Korea | South Korea |
| Seoul | Korea | South Korea |
| Yangsan | Korea | South Korea |
| Changhua | Taiwan | Taiwan |
| Kaohsiung City | Taiwan | Taiwan |
| Taipei | Taiwan | Taiwan |
| Taoyuan Hsien | Taiwan | Taiwan |
| Chernigiv Region | Ukraine | Ukraine |
| Dnipropetrovsk | Ukraine | Ukraine |
| Kharkiv | Ukraine | Ukraine |
| Kiev | Ukraine | Ukraine |
| Luhansk | Ukraine | Ukraine |
| Nishimura A, Aritomi Y, Sasai K, Kitagawa T, Mahableshwarkar AR. Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder. Psychiatry Clin Neurosci. 2018 Feb;72(2):64-72. doi: 10.1111/pcn.12565. Epub 2017 Oct 3. |
| FG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
| FG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. |
| BG001 | Vortioxetine 5 mg | Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
| BG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. |
| BG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Number of participants for whom weight data were available were 152, 144, 147 and 149 in each treatment group respectively. | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index (BMI) | Number of participants for whom BMI data were available were 152, 144, 147 and 149 in each treatment group respectively. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Smoking Classification | Number | participants |
| ||||||||||||||||
| History of Alcohol Consumption | Number | participants |
| ||||||||||||||||
| Status of Major Depressive Episode (MDE) | An MDE is a period marked by depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. | Number | participants |
| |||||||||||||||
| Pharmacotherapy for Current Major Depressive Episode | Number | participants |
| ||||||||||||||||
| Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Number of participants for whom MADRS data were available were 152, 144, 147 and 149 in each treatment arm respectively. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Clinical Global Impression - Severity scale score | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Number of participants for whom CGI-S data were available were 152, 144, 147 and 149 in each treatment arm respectively. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Sheehan Disability Scale (SDS) - Total score | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. Number of participants for whom SDS data were available were 132, 116, 119 and 121 in each treatment arm respectively. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Hamilton Anxiety Scale Total Score | Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (absent) to 56 (maximum severity). Number of participants for whom HAM-A data were available were 152, 144, 148 and 150 in each treatment arm respectively. | Mean | Standard Deviation | scores on a scale |
|
| 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 | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate. | The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a MADRS Response at Week 8 | Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used. | Posted | Number | percentage of participants | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in MADRS Remission at Week 8 | Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 | The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate. | Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used. | Posted | Least Squares Mean | Standard Error | scores on a scale | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate. | Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 8 |
|
A treatment-emergent adverse event is defined as any AE whose onset occurs or intensity increases after the first dose of double-blind study medication through 2 weeks after the last dose of double-blind study medication.
The safety analysis set included all patients who received at least 1 dose of study drug. One patient in the placebo arm was excluded due to enrollment in another clinical study. Any event spontaneously reported by the patient or observed by the investigator was recorded, irrespective of relation to 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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. | 1 | 151 | 97 | 151 | ||
| EG001 | Vortioxetine 5 mg | Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. | 2 | 144 | 96 | 144 | ||
| EG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. | 2 | 148 | 93 | 148 | ||
| EG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. | 3 | 150 | 106 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Finland |
|
| Germany |
|
| India |
|
| Japan |
|
| Latvia |
|
| Malaysia |
|
| Philippines |
|
| Poland |
|
| Romania |
|
| Russia |
|
| Serbia |
|
| South Korea |
|
| Ukraine |
|
| Ex-smoker |
|
| Never smoked |
|
| Once monthly or less often |
|
| Once a week |
|
| 2 to 6 times per week |
|
| Daily |
|
| Recurrent episode |
|
| No |
|
| ANCOVA | Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate. | 0.3006 | LS Mean Difference | -1.69 | Standard Error of the Mean | 1.114 | 2-Sided | 95 | -4.310 | 0.938 | No | Superiority or Other |
| ANCOVA | Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate. | 0.2399 | LS Mean Difference | -1.82 | Standard Error of the Mean | 1.110 | 2-Sided | 95 | -4.436 | 0.794 | No | Superiority or Other |
| OG003 |
| Vortioxetine 20 mg |
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
|
|
| Vortioxetine 20 mg |
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
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| OG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
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| OG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. |
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