Trial Outcomes & Findings for Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder (NCT NCT01355081)

Last Updated: 2014-11-11

Results Overview

MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

366 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2014-11-11

Participant Flow

Participants took part in the study at 32 investigative sites throughout Japan from 13 May 2011 to 21 December 2012.

Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups: once a day 5 mg or 10 mg vortioxetine (Lu AA21004) or placebo.

Participant milestones

Participant milestones
Measure	Vortioxetine 5 mg Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Study STARTED	119	123	124
Overall Study COMPLETED	112	113	113
Overall Study NOT COMPLETED	7	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Vortioxetine 5 mg Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Overall Study Pretreatment Event or Adverse Event	3	4	6
Overall Study Major Protocol Deviation	0	1	0
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal of Consent	2	3	3
Overall Study Lack of Efficacy	2	1	1
Overall Study Non Compliance with Study Medication	0	1	0

Baseline Characteristics

Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=123 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=124 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.	Total n=366 Participants Total of all reporting groups
Age, Continuous	38.8 years STANDARD_DEVIATION 10.85 • n=5 Participants	38.8 years STANDARD_DEVIATION 10.99 • n=7 Participants	37.6 years STANDARD_DEVIATION 10.67 • n=5 Participants	38.4 years STANDARD_DEVIATION 10.83 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	54 Participants n=7 Participants	67 Participants n=5 Participants	171 Participants n=4 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	69 Participants n=7 Participants	57 Participants n=5 Participants	195 Participants n=4 Participants
Region of Enrollment Japan	119 participants n=5 Participants	123 participants n=7 Participants	124 participants n=5 Participants	366 participants n=4 Participants
Height	165.7 cm STANDARD_DEVIATION 8.45 • n=5 Participants	165.6 cm STANDARD_DEVIATION 8.51 • n=7 Participants	163.9 cm STANDARD_DEVIATION 8.46 • n=5 Participants	165.1 cm STANDARD_DEVIATION 8.49 • n=4 Participants
Weight	62.18 kg STANDARD_DEVIATION 11.357 • n=5 Participants	62.11 kg STANDARD_DEVIATION 15.883 • n=7 Participants	60.86 kg STANDARD_DEVIATION 12.690 • n=5 Participants	61.71 kg STANDARD_DEVIATION 13.441 • n=4 Participants
Body Mass Index (BMI)	22.59 kg/m^2 STANDARD_DEVIATION 3.366 • n=5 Participants	22.42 kg/m^2 STANDARD_DEVIATION 4.306 • n=7 Participants	22.57 kg/m^2 STANDARD_DEVIATION 4.016 • n=5 Participants	22.53 kg/m^2 STANDARD_DEVIATION 3.911 • n=4 Participants
Cytochrome p450 (CYP)2D6 Phenotype Ultra-rapid Metabolizer (UM)	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Cytochrome p450 (CYP)2D6 Phenotype Extensive Metabolizer (EM)	91 participants n=5 Participants	97 participants n=7 Participants	96 participants n=5 Participants	284 participants n=4 Participants
Cytochrome p450 (CYP)2D6 Phenotype Intermediate Metabolizer (IM)	25 participants n=5 Participants	20 participants n=7 Participants	21 participants n=5 Participants	66 participants n=4 Participants
Cytochrome p450 (CYP)2D6 Phenotype Poor Metabolizer (PM)	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Cytochrome p450 (CYP)2D6 Phenotype Unknown	2 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants
Smoking Classification Current smoker	39 participants n=5 Participants	41 participants n=7 Participants	40 participants n=5 Participants	120 participants n=4 Participants
Smoking Classification Ex-smoker	26 participants n=5 Participants	24 participants n=7 Participants	24 participants n=5 Participants	74 participants n=4 Participants
Smoking Classification Never Smoked	54 participants n=5 Participants	58 participants n=7 Participants	60 participants n=5 Participants	172 participants n=4 Participants
History of Alcohol Consumption Never	34 participants n=5 Participants	32 participants n=7 Participants	41 participants n=5 Participants	107 participants n=4 Participants
History of Alcohol Consumption Once Monthly or Less Often	33 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	113 participants n=4 Participants
History of Alcohol Consumption Once a Week	16 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	56 participants n=4 Participants
History of Alcohol Consumption 2 to 6 Times/Week	21 participants n=5 Participants	20 participants n=7 Participants	15 participants n=5 Participants	56 participants n=4 Participants
History of Alcohol Consumption Daily	15 participants n=5 Participants	11 participants n=7 Participants	8 participants n=5 Participants	34 participants n=4 Participants
Status of Major Depressive Episode (MDE) Single episode	70 participants n=5 Participants	68 participants n=7 Participants	76 participants n=5 Participants	214 participants n=4 Participants
Status of Major Depressive Episode (MDE) Recurrent episode	49 participants n=5 Participants	55 participants n=7 Participants	48 participants n=5 Participants	152 participants n=4 Participants
Pharmacotherapy for Current Major Depressive Episode Yes	68 participants n=5 Participants	68 participants n=7 Participants	74 participants n=5 Participants	210 participants n=4 Participants
Pharmacotherapy for Current Major Depressive Episode No	51 participants n=5 Participants	55 participants n=7 Participants	50 participants n=5 Participants	156 participants n=4 Participants
Montgomery Åsberg Depression Rating Scale (MADRS) Total Score	32.2 scores on a scale STANDARD_DEVIATION 4.81 • n=5 Participants	32.5 scores on a scale STANDARD_DEVIATION 4.93 • n=7 Participants	32.5 scores on a scale STANDARD_DEVIATION 4.50 • n=5 Participants	32.4 scores on a scale STANDARD_DEVIATION 4.74 • n=4 Participants
Hamilton Depression Scale (HAM-D17) Total Score	20.9 scores on a scale STANDARD_DEVIATION 4.12 • n=5 Participants	21.2 scores on a scale STANDARD_DEVIATION 4.43 • n=7 Participants	21.5 scores on a scale STANDARD_DEVIATION 4.48 • n=5 Participants	21.2 scores on a scale STANDARD_DEVIATION 4.34 • n=4 Participants
Clinical Global Impression - Severity Scale Score	4.5 scores on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	4.6 scores on a scale STANDARD_DEVIATION 0.69 • n=5 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.66 • n=4 Participants
Sheehan Disability Scale (SDS) - Total Score	15.5 scores on a scale STANDARD_DEVIATION 6.12 • n=5 Participants	15.2 scores on a scale STANDARD_DEVIATION 5.97 • n=7 Participants	15.4 scores on a scale STANDARD_DEVIATION 5.45 • n=5 Participants	15.4 scores on a scale STANDARD_DEVIATION 5.83 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=122 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=123 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment	-15.84 scores on a scale Standard Error 0.885	-14.85 scores on a scale Standard Error 0.874	-13.81 scores on a scale Standard Error 0.870

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=122 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=123 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Percentage of Patients With MADRS Response After 8 Weeks of Treatment	51.3 percentage of participants	45.9 percentage of participants	39.8 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=122 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=123 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Percentage of Patients With MADRS Remission After 8 Weeks of Treatment	29.4 percentage of participants	28.7 percentage of participants	22.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8

The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=121 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=122 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment	-9.56 scores on a scale Standard Error 0.586	-8.54 scores on a scale Standard Error 0.580	-8.40 scores on a scale Standard Error 0.578

SECONDARY outcome

Timeframe: Baseline, Week 8

The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=122 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=123 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment	2.44 scores on a scale Standard Error 0.100	2.57 scores on a scale Standard Error 0.099	2.66 scores on a scale Standard Error 0.099

SECONDARY outcome

Timeframe: Baseline, Week 8

The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.

Outcome measures

Outcome measures
Measure	Vortioxetine 5 mg n=119 Participants Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=121 Participants Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=122 Participants Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment	-5.01 scores on a scale Standard Error 0.510	-4.02 scores on a scale Standard Error 0.506	-2.91 scores on a scale Standard Error 0.504

Adverse Events

Vortioxetine 5 mg

Serious events: 1 serious events

Other events: 80 other events

Deaths: 0 deaths

Vortioxetine 10 mg

Serious events: 1 serious events

Other events: 93 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vortioxetine 5 mg n=119 participants at risk Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.	Vortioxetine 10 mg n=122 participants at risk Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.	Placebo n=124 participants at risk Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Injury, poisoning and procedural complications Brain contusion	0.84% 1/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
Injury, poisoning and procedural complications Road traffic accident	0.84% 1/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.81% 1/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
Nervous system disorders Cerebral haematoma	0.84% 1/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
Nervous system disorders Subarachnoid haemorrhage	0.84% 1/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.
Psychiatric disorders Suicidal behaviour	0.00% 0/119 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.82% 1/122 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.	0.00% 0/124 • 8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks) At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. Safety analysis set included all participants who received study drug. 1 participant in the Vortioxetine 10 mg group was excluded due to a major protocol violation.

Other adverse events

Additional Information

Medical Director, Clinical Science

Takeda

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER