Trial Outcomes & Findings for Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder (NCT NCT00672620)

Last Updated: 2013-12-18

Results Overview

The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

611 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2013-12-18

Participant Flow

Participants took part in the study at 47 investigative sites in the United States from 10 April 2008 to 30 December 2008.

Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 2.5 mg, 5 mg vortioxetine, or 60 mg duloxetine.

Participant milestones

Participant milestones
Measure	Placebo Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
Overall Study STARTED	153	153	153	152
Overall Study Treated	151	149	153	150
Overall Study COMPLETED	120	99	122	110
Overall Study NOT COMPLETED	33	54	31	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
Overall Study Adverse Event	7	7	12	17
Overall Study Lack of Efficacy	1	2	2	0
Overall Study Noncompliance with Study Drug	3	4	0	2
Overall Study Protocol Deviations	5	7	2	5
Overall Study Withdrawal of Consent	6	12	5	6
Overall Study Lost to Follow-up	8	19	8	11
Overall Study Reason not Specified	3	3	2	1

Baseline Characteristics

Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=153 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=153 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=152 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.	Total n=611 Participants Total of all reporting groups
Age Continuous	42.6 years STANDARD_DEVIATION 13.76 • n=5 Participants	42.6 years STANDARD_DEVIATION 12.85 • n=7 Participants	43.1 years STANDARD_DEVIATION 13.89 • n=5 Participants	42.7 years STANDARD_DEVIATION 14.38 • n=4 Participants	42.7 years STANDARD_DEVIATION 13.70 • n=21 Participants
Age, Customized ≤55 years	122 participants n=5 Participants	127 participants n=7 Participants	125 participants n=5 Participants	123 participants n=4 Participants	497 participants n=21 Participants
Age, Customized >55 years	31 participants n=5 Participants	26 participants n=7 Participants	28 participants n=5 Participants	29 participants n=4 Participants	114 participants n=21 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	98 Participants n=7 Participants	106 Participants n=5 Participants	91 Participants n=4 Participants	388 Participants n=21 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	55 Participants n=7 Participants	47 Participants n=5 Participants	61 Participants n=4 Participants	223 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian (White, including Hispanic)	121 participants n=5 Participants	112 participants n=7 Participants	108 participants n=5 Participants	111 participants n=4 Participants	452 participants n=21 Participants
Race/Ethnicity, Customized Black	28 participants n=5 Participants	35 participants n=7 Participants	40 participants n=5 Participants	36 participants n=4 Participants	139 participants n=21 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	12 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian/ Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Hispanic/Latino	35 participants n=5 Participants	21 participants n=7 Participants	19 participants n=5 Participants	28 participants n=4 Participants	103 participants n=21 Participants
Race/Ethnicity, Customized Non-Hispanic/Non-Latino	118 participants n=5 Participants	132 participants n=7 Participants	133 participants n=5 Participants	123 participants n=4 Participants	506 participants n=21 Participants
Region of Enrollment United States	153 participants n=5 Participants	153 participants n=7 Participants	153 participants n=5 Participants	152 participants n=4 Participants	611 participants n=21 Participants
Weight	84.22 kg STANDARD_DEVIATION 20.144 • n=5 Participants	85.08 kg STANDARD_DEVIATION 24.126 • n=7 Participants	88.61 kg STANDARD_DEVIATION 25.779 • n=5 Participants	87.44 kg STANDARD_DEVIATION 20.695 • n=4 Participants	86.34 kg STANDARD_DEVIATION 22.823 • n=21 Participants
Height	168.98 cm STANDARD_DEVIATION 9.141 • n=5 Participants	169.50 cm STANDARD_DEVIATION 9.385 • n=7 Participants	167.98 cm STANDARD_DEVIATION 9.833 • n=5 Participants	170.37 cm STANDARD_DEVIATION 9.624 • n=4 Participants	169.21 cm STANDARD_DEVIATION 9.515 • n=21 Participants
Body Mass Index (BMI)	29.58 kg/m^2 STANDARD_DEVIATION 7.263 • n=5 Participants	29.48 kg/m^2 STANDARD_DEVIATION 7.479 • n=7 Participants	31.38 kg/m^2 STANDARD_DEVIATION 8.846 • n=5 Participants	30.14 kg/m^2 STANDARD_DEVIATION 6.773 • n=4 Participants	30.15 kg/m^2 STANDARD_DEVIATION 7.649 • n=21 Participants
Smoking Classification Never smoked	72 participants n=5 Participants	81 participants n=7 Participants	87 participants n=5 Participants	75 participants n=4 Participants	315 participants n=21 Participants
Smoking Classification Current smoker	47 participants n=5 Participants	42 participants n=7 Participants	45 participants n=5 Participants	36 participants n=4 Participants	170 participants n=21 Participants
Smoking Classification Ex-smoker	34 participants n=5 Participants	30 participants n=7 Participants	21 participants n=5 Participants	41 participants n=4 Participants	126 participants n=21 Participants
Alcohol consumption Never	50 participants n=5 Participants	49 participants n=7 Participants	48 participants n=5 Participants	49 participants n=4 Participants	196 participants n=21 Participants
Alcohol consumption Once monthly or less often	56 participants n=5 Participants	49 participants n=7 Participants	62 participants n=5 Participants	51 participants n=4 Participants	218 participants n=21 Participants
Alcohol consumption Once per week	23 participants n=5 Participants	26 participants n=7 Participants	23 participants n=5 Participants	21 participants n=4 Participants	93 participants n=21 Participants
Alcohol consumption 2-to-6 times/week	22 participants n=5 Participants	20 participants n=7 Participants	17 participants n=5 Participants	28 participants n=4 Participants	87 participants n=21 Participants
Alcohol consumption Daily	2 participants n=5 Participants	9 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	17 participants n=21 Participants
24-item Hamilton Depression Scale total score	29.5 scores on a scale STANDARD_DEVIATION 6.05 • n=5 Participants	29.8 scores on a scale STANDARD_DEVIATION 5.42 • n=7 Participants	29.8 scores on a scale STANDARD_DEVIATION 5.58 • n=5 Participants	28.7 scores on a scale STANDARD_DEVIATION 5.08 • n=4 Participants	29.5 scores on a scale STANDARD_DEVIATION 5.55 • n=21 Participants
Montgomery Åsberg Depression Rating Scale (MADRS) total score	30.0 scores on a scale STANDARD_DEVIATION 4.39 • n=5 Participants	29.8 scores on a scale STANDARD_DEVIATION 4.61 • n=7 Participants	30.1 scores on a scale STANDARD_DEVIATION 4.51 • n=5 Participants	29.4 scores on a scale STANDARD_DEVIATION 4.31 • n=4 Participants	29.8 scores on a scale STANDARD_DEVIATION 4.45 • n=21 Participants
Hamilton Anxiety Scale Total Score	18.8 scores on a scale STANDARD_DEVIATION 5.53 • n=5 Participants	19.3 scores on a scale STANDARD_DEVIATION 5.22 • n=7 Participants	18.7 scores on a scale STANDARD_DEVIATION 5.74 • n=5 Participants	17.4 scores on a scale STANDARD_DEVIATION 5.47 • n=4 Participants	18.5 scores on a scale STANDARD_DEVIATION 5.53 • n=21 Participants
Clinical Global Impression - Severity scale score	4.5 scores on a scale STANDARD_DEVIATION 0.62 • n=5 Participants	4.6 scores on a scale STANDARD_DEVIATION 0.62 • n=7 Participants	4.6 scores on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.67 • n=4 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.64 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8	-10.50 scores on a scale Standard Error 0.757	-12.04 scores on a scale Standard Error 0.744	-11.08 scores on a scale Standard Error 0.737	-13.47 scores on a scale Standard Error 0.750

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, and 6

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed Week 1 (n=142, 143, 150, 147)	-5.12 scores on a scale Standard Error 0.515	-5.44 scores on a scale Standard Error 0.497	-5.28 scores on a scale Standard Error 0.491	-5.66 scores on a scale Standard Error 0.500
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed Week 2 (n=149, 146, 153, 149)	-7.19 scores on a scale Standard Error 0.567	-7.95 scores on a scale Standard Error 0.557	-7.99 scores on a scale Standard Error 0.552	-8.42 scores on a scale Standard Error 0.562
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed Week 4 (n=149, 146, 153, 149)	-9.39 scores on a scale Standard Error 0.663	-9.94 scores on a scale Standard Error 0.651	-8.96 scores on a scale Standard Error 0.645	-10.88 scores on a scale Standard Error 0.657
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed Week 6 (n=149, 146, 153, 149)	-10.43 scores on a scale Standard Error 0.706	-11.21 scores on a scale Standard Error 0.694	-10.97 scores on a scale Standard Error 0.687	-12.78 scores on a scale Standard Error 0.700

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Percentage of Responders in HAM-D 24 Total Score by Study Visit Week 1 (n=142, 143, 150, 147)	9.2 percentage of participants	8.4 percentage of participants	8.7 percentage of participants	10.2 percentage of participants
Percentage of Responders in HAM-D 24 Total Score by Study Visit Week 2 (n=149, 146, 153, 149)	15.4 percentage of participants	17.1 percentage of participants	17.6 percentage of participants	22.1 percentage of participants
Percentage of Responders in HAM-D 24 Total Score by Study Visit Week 4 (n=149, 146, 153, 149)	26.2 percentage of participants	30.8 percentage of participants	24.2 percentage of participants	34.9 percentage of participants
Percentage of Responders in HAM-D 24 Total Score by Study Visit Week 6 (n=149, 146, 153, 149)	32.9 percentage of participants	37.7 percentage of participants	37.3 percentage of participants	47.0 percentage of participants
Percentage of Responders in HAM-D 24 Total Score by Study Visit Week 8 (n=149, 146, 153, 149)	32.2 percentage of participants	41.1 percentage of participants	37.9 percentage of participants	51.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: Full analysis set with available data.

A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Percentage of Participants With a Sustained Response in HAM-D24	12.1 percentage of participants	15.8 percentage of participants	17.0 percentage of participants	21.5 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Full analysis set; LOCF was used.

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.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Percentage of Participants in MADRS Remission at Week 8	22.8 percentage of participants	28.8 percentage of participants	23.5 percentage of participants	37.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

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). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Week 1 (n=142, 143, 150, 147)	-4.90 scores on a scale Standard Error 0.530	-5.16 scores on a scale Standard Error 0.511	-5.06 scores on a scale Standard Error 0.505	-5.49 scores on a scale Standard Error 0.514
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Week 2 (n=149, 146, 153, 149)	-7.57 scores on a scale Standard Error 0.615	-7.71 scores on a scale Standard Error 0.605	-7.81 scores on a scale Standard Error 0.599	-8.95 scores on a scale Standard Error 0.609
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Week 4 (n=149, 146, 153, 149)	-9.66 scores on a scale Standard Error 0.693	-9.58 scores on a scale Standard Error 0.681	-9.35 scores on a scale Standard Error 0.675	-11.34 scores on a scale Standard Error 0.686
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Week 6 (n=149, 146, 153, 149)	-11.04 scores on a scale Standard Error 0.770	-11.25 scores on a scale Standard Error 0.757	-11.27 scores on a scale Standard Error 0.750	-13.29 scores on a scale Standard Error 0.763
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Week 8 (149, 146, 153, 149)	-11.22 scores on a scale Standard Error 0.819	-11.61 scores on a scale Standard Error 0.805	-11.30 scores on a scale Standard Error 0.797	-14.10 scores on a scale Standard Error 0.811

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

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 and center as fixed factors and the CGI-S Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Clinical Global Impression Scale-Global Improvement Scale Week 1 (n=142, 143, 149, 147)	3.54 scores on a scale Standard Error 0.067	3.42 scores on a scale Standard Error 0.065	3.46 scores on a scale Standard Error 0.064	3.31 scores on a scale Standard Error 0.065
Clinical Global Impression Scale-Global Improvement Scale Week 2 (n=149, 146, 153, 149)	3.21 scores on a scale Standard Error 0.077	3.17 scores on a scale Standard Error 0.076	3.10 scores on a scale Standard Error 0.075	2.99 scores on a scale Standard Error 0.076
Clinical Global Impression Scale-Global Improvement Scale Week 4 (149, 146, 153, 149)	2.97 scores on a scale Standard Error 0.085	2.93 scores on a scale Standard Error 0.084	2.87 scores on a scale Standard Error 0.083	2.73 scores on a scale Standard Error 0.084
Clinical Global Impression Scale-Global Improvement Scale Week 6 (149, 146, 153, 149)	2.83 scores on a scale Standard Error 0.091	2.82 scores on a scale Standard Error 0.090	2.74 scores on a scale Standard Error 0.089	2.50 scores on a scale Standard Error 0.090
Clinical Global Impression Scale-Global Improvement Scale Week 8 (n=149, 146, 153, 149)	2.79 scores on a scale Standard Error 0.098	2.73 scores on a scale Standard Error 0.096	2.63 scores on a scale Standard Error 0.095	2.39 scores on a scale Standard Error 0.097

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4 and 8

Population: Full analysis set with available data at Baseline; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=148 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=145 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=152 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) Week 1 (n=141, 142, 149, 146)	-2.51 scores on a scale Standard Error 0.310	-2.43 scores on a scale Standard Error 0.299	-2.74 scores on a scale Standard Error 0.295	-2.88 scores on a scale Standard Error 0.299
Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) Week 4 (148, 145, 152, 149)	-4.02 scores on a scale Standard Error 0.348	-3.65 scores on a scale Standard Error 0.342	-3.69 scores on a scale Standard Error 0.338	-4.89 scores on a scale Standard Error 0.342
Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) Week 8 (n=148, 145, 152, 149)	-4.25 scores on a scale Standard Error 0.370	-3.98 scores on a scale Standard Error 0.364	-4.04 scores on a scale Standard Error 0.360	-5.70 scores on a scale Standard Error 0.364

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

The 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 to 56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Week 1 (n=142, 143, 150, 147)	-2.63 scores on a scale Standard Error 0.356	-2.98 scores on a scale Standard Error 0.343	-2.55 scores on a scale Standard Error 0.339	-2.30 scores on a scale Standard Error 0.346
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Week 2 (n=149, 146, 153, 149)	-3.82 scores on a scale Standard Error 0.419	-4.41 scores on a scale Standard Error 0.412	-3.76 scores on a scale Standard Error 0.408	-3.94 scores on a scale Standard Error 0.415
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Week 4 (n=149, 146, 153, 149)	-5.12 scores on a scale Standard Error 0.457	-5.10 scores on a scale Standard Error 0.450	-4.25 scores on a scale Standard Error 0.445	-4.88 scores on a scale Standard Error 0.454
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Week 6 (n=149, 146, 153, 149)	-5.84 scores on a scale Standard Error 0.482	-5.77 scores on a scale Standard Error 0.474	-4.89 scores on a scale Standard Error 0.469	-6.15 scores on a scale Standard Error 0.478
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score Week 8 (n=149, 146, 153, 149)	-5.75 scores on a scale Standard Error 0.502	-5.91 scores on a scale Standard Error 0.494	-5.29 scores on a scale Standard Error 0.488	-6.56 scores on a scale Standard Error 0.498

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.

Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate 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. Considering total clinical experience, a patient is assessed on severity of mental illness 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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale Week 1 (n=142, 143, 150, 147)	-0.28 scores on a scale Standard Error 0.055	-0.40 scores on a scale Standard Error 0.053	-0.37 scores on a scale Standard Error 0.053	-0.44 scores on a scale Standard Error 0.054
Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale Week 2 (n=149, 146, 153, 149)	-0.63 scores on a scale Standard Error 0.071	-0.65 scores on a scale Standard Error 0.069	-0.66 scores on a scale Standard Error 0.069	-0.75 scores on a scale Standard Error 0.070
Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale Week 4 (n=149, 146, 153, 149)	-0.92 scores on a scale Standard Error 0.086	-0.92 scores on a scale Standard Error 0.085	-0.90 scores on a scale Standard Error 0.084	-1.12 scores on a scale Standard Error 0.085
Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale Week 6 (n=149, 146, 153, 149)	-1.11 scores on a scale Standard Error 0.094	-1.08 scores on a scale Standard Error 0.092	-1.08 scores on a scale Standard Error 0.091	-1.39 scores on a scale Standard Error 0.093
Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale Week 8 (n=149, 146, 153, 149)	-1.14 scores on a scale Standard Error 0.103	-1.21 scores on a scale Standard Error 0.102	-1.17 scores on a scale Standard Error 0.101	-1.56 scores on a scale Standard Error 0.102

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set with available data at Baseline; LOCF was used.

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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=122 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=123 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=114 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8	-6.83 scores on a scale Standard Error 0.638	-6.46 scores on a scale Standard Error 0.640	-6.59 scores on a scale Standard Error 0.641	-8.91 scores on a scale Standard Error 0.672

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set

Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=146 Participants Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 Participants Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=149 Participants Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Baseline: Any resource use	40 participants	51 participants	42 participants	42 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Baseline: Any hospitalization-related services	4 participants	1 participants	0 participants	3 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Baseline: Hospitalization related to depression	2 participants	1 participants	0 participants	0 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Baseline: Any sick leave	18 participants	11 participants	11 participants	14 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Baseline: Sick leave related to depression	13 participants	9 participants	10 participants	11 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Week 8: Any resource use	21 participants	19 participants	20 participants	27 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Week 8: Any hospitalization-related service	1 participants	0 participants	1 participants	2 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Week 8: Hospitalization related to depression	0 participants	0 participants	0 participants	1 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Week 8: Any sick leave	5 participants	5 participants	9 participants	5 participants
Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire Week 8: Sick leave related to depression	2 participants	4 participants	3 participants	2 participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 81 other events

Deaths: 0 deaths

Vortioxetine 2.5 mg

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Vortioxetine 5 mg

Serious events: 3 serious events

Other events: 87 other events

Deaths: 0 deaths

Duloxetine 60 mg

Serious events: 2 serious events

Other events: 120 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=151 participants at risk Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 2.5 mg n=149 participants at risk Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Vortioxetine 5 mg n=153 participants at risk Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.	Duloxetine 60 mg n=150 participants at risk Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
Cardiac disorders Acute myocardial infarction	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.67% 1/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.65% 1/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.65% 1/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.65% 1/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Convulsion	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.65% 1/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Depression	0.66% 1/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Panic attack	0.00% 0/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.67% 1/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Surgical and medical procedures Abortion induced	0.66% 1/151 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/149 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/153 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/150 • Adverse events were collected during the 8-week treatment period and a 4-week follow-up period. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

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