Trial Outcomes & Findings for Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder (NCT NCT01153009)

Last Updated: 2013-12-18

Results Overview

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 are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

614 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2013-12-18

Participant Flow

Participants took part in the study at 58 investigative sites in the United States from 22 June 2010 to 20 March 2012.

Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 15 mg vortioxetine, 20 mg vortioxetine, or 60 mg duloxetine.

Participant milestones

Participant milestones
Measure	Placebo Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Overall Study STARTED	161	147	154	152
Overall Study Treated	159	147	154	150
Overall Study COMPLETED	129	113	113	115
Overall Study NOT COMPLETED	32	34	41	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Overall Study Adverse Event	4	14	14	10
Overall Study Lack of Efficacy	9	0	2	1
Overall Study Noncompliance with Study Medication	1	3	4	1
Overall Study Protocol Deviations	4	3	3	2
Overall Study Withdrawal of Consent	5	5	4	6
Overall Study Lost to Follow-up	8	8	11	15
Overall Study Other	1	1	3	2

Baseline Characteristics

Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=161 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=147 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=154 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=152 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.	Total n=614 Participants Total of all reporting groups
Age Continuous	42.4 years STANDARD_DEVIATION 12.55 • n=5 Participants	43.1 years STANDARD_DEVIATION 12.28 • n=7 Participants	42.8 years STANDARD_DEVIATION 12.40 • n=5 Participants	43.4 years STANDARD_DEVIATION 12.24 • n=4 Participants	42.9 years STANDARD_DEVIATION 12.35 • n=21 Participants
Age, Customized ≤55 years	138 participants n=5 Participants	125 participants n=7 Participants	132 participants n=5 Participants	126 participants n=4 Participants	521 participants n=21 Participants
Age, Customized >55 years	23 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	26 participants n=4 Participants	93 participants n=21 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	104 Participants n=7 Participants	114 Participants n=5 Participants	119 Participants n=4 Participants	453 Participants n=21 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	33 Participants n=4 Participants	161 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	18 participants n=5 Participants	20 participants n=7 Participants	18 participants n=5 Participants	23 participants n=4 Participants	79 participants n=21 Participants
Race/Ethnicity, Customized Non-Hispanic and non-Latino	143 participants n=5 Participants	127 participants n=7 Participants	136 participants n=5 Participants	129 participants n=4 Participants	535 participants n=21 Participants
Race/Ethnicity, Customized Caucasian (or White, including Hispanic)	122 participants n=5 Participants	114 participants n=7 Participants	115 participants n=5 Participants	119 participants n=4 Participants	470 participants n=21 Participants
Race/Ethnicity, Customized Black	37 participants n=5 Participants	31 participants n=7 Participants	36 participants n=5 Participants	32 participants n=4 Participants	136 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Region of Enrollment United States	161 participants n=5 Participants	147 participants n=7 Participants	154 participants n=5 Participants	152 participants n=4 Participants	614 participants n=21 Participants
Height	168.46 cm STANDARD_DEVIATION 9.757 • n=5 Participants	167.23 cm STANDARD_DEVIATION 8.254 • n=7 Participants	168.03 cm STANDARD_DEVIATION 9.530 • n=5 Participants	166.40 cm STANDARD_DEVIATION 9.851 • n=4 Participants	167.55 cm STANDARD_DEVIATION 9.395 • n=21 Participants
Weight	88.61 kg STANDARD_DEVIATION 24.786 • n=5 Participants	87.42 kg STANDARD_DEVIATION 21.431 • n=7 Participants	87.44 kg STANDARD_DEVIATION 23.806 • n=5 Participants	87.16 kg STANDARD_DEVIATION 24.196 • n=4 Participants	87.67 kg STANDARD_DEVIATION 23.574 • n=21 Participants
Body Mass Index (BMI)	31.13 kg/m^2 STANDARD_DEVIATION 7.882 • n=5 Participants	31.26 kg/m^2 STANDARD_DEVIATION 7.476 • n=7 Participants	30.92 kg/m^2 STANDARD_DEVIATION 7.633 • n=5 Participants	31.49 kg/m^2 STANDARD_DEVIATION 8.448 • n=4 Participants	31.20 kg/m^2 STANDARD_DEVIATION 7.855 • n=21 Participants
Waist circumference	98.73 cm STANDARD_DEVIATION 18.232 • n=5 Participants	96.86 cm STANDARD_DEVIATION 16.116 • n=7 Participants	96.47 cm STANDARD_DEVIATION 18.301 • n=5 Participants	97.73 cm STANDARD_DEVIATION 17.971 • n=4 Participants	97.47 cm STANDARD_DEVIATION 17.678 • n=21 Participants
Smoking classification Never smoked	82 participants n=5 Participants	79 participants n=7 Participants	73 participants n=5 Participants	75 participants n=4 Participants	309 participants n=21 Participants
Smoking classification Current smoker	46 participants n=5 Participants	38 participants n=7 Participants	41 participants n=5 Participants	39 participants n=4 Participants	164 participants n=21 Participants
Smoking classification Ex-smoker	33 participants n=5 Participants	30 participants n=7 Participants	40 participants n=5 Participants	38 participants n=4 Participants	141 participants n=21 Participants
Alcohol consumption Never	61 participants n=5 Participants	48 participants n=7 Participants	61 participants n=5 Participants	67 participants n=4 Participants	237 participants n=21 Participants
Alcohol consumption Once monthly or less often	58 participants n=5 Participants	55 participants n=7 Participants	45 participants n=5 Participants	54 participants n=4 Participants	212 participants n=21 Participants
Alcohol consumption Once per week	24 participants n=5 Participants	23 participants n=7 Participants	24 participants n=5 Participants	17 participants n=4 Participants	88 participants n=21 Participants
Alcohol consumption 2 to 6 times per week	16 participants n=5 Participants	19 participants n=7 Participants	21 participants n=5 Participants	14 participants n=4 Participants	70 participants n=21 Participants
Alcohol consumption Daily	2 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	0 participants n=4 Participants	7 participants n=21 Participants
Montgomery Åsberg Depression Rating Scale (MADRS) total score	31.6 scores on a scale STANDARD_DEVIATION 4.18 • n=5 Participants	31.9 scores on a scale STANDARD_DEVIATION 4.08 • n=7 Participants	32.0 scores on a scale STANDARD_DEVIATION 4.36 • n=5 Participants	32.9 scores on a scale STANDARD_DEVIATION 4.39 • n=4 Participants	32.1 scores on a scale STANDARD_DEVIATION 4.27 • n=21 Participants
Hamilton Anxiety Scale Total Score	17.0 scores on a scale STANDARD_DEVIATION 5.12 • n=5 Participants	17.5 scores on a scale STANDARD_DEVIATION 5.28 • n=7 Participants	17.8 scores on a scale STANDARD_DEVIATION 5.42 • n=5 Participants	18.4 scores on a scale STANDARD_DEVIATION 5.81 • n=4 Participants	17.7 scores on a scale STANDARD_DEVIATION 5.42 • n=21 Participants
Clinical Global Impression - Severity scale score	4.6 scores on a scale STANDARD_DEVIATION 0.58 • n=5 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.55 • n=7 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.60 • n=5 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.60 • n=4 Participants	4.5 scores on a scale STANDARD_DEVIATION 0.58 • 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 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.

Outcome measures

Outcome measures
Measure	Placebo n=129 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=113 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=112 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=115 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-12.83 scores on a scale Standard Error 0.834	-14.30 scores on a scale Standard Error 0.890	-15.57 scores on a scale Standard Error 0.880	-16.90 scores on a scale Standard Error 0.884

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set, last observation carried forward was used.

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.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=145 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=147 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=146 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Percentage of Participants With a MADRS Response at Week 8	39.2 percentage of participants	44.1 percentage of participants	44.2 percentage of participants	54.8 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.

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 a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo n=129 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=112 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=111 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=115 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8	2.65 scores on a scale Standard Error 0.096	2.54 scores on a scale Standard Error 0.102	2.47 scores on a scale Standard Error 0.101	2.31 scores on a scale Standard Error 0.101

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.

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. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects. HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=44 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=34 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=47 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20	-14.27 scores on a scale Standard Error 1.676	-13.34 scores on a scale Standard Error 1.624	-14.89 scores on a scale Standard Error 1.777	-18.31 scores on a scale Standard Error 1.573

SECONDARY outcome

Timeframe: Week 8

Population: Full analysis set, last observation carried forward 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=153 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=145 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=147 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=146 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Percentage of Participants in MADRS Remission at Week 8	26.8 percentage of participants	26.9 percentage of participants	29.3 percentage of participants	26.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases 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 mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=77 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=77 Participants Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=73 Participants Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8	-7.68 scores on a scale Standard Error 0.776	-7.73 scores on a scale Standard Error 0.821	-8.55 scores on a scale Standard Error 0.810	-9.66 scores on a scale Standard Error 0.834

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

Vortioxetine 15 mg

Serious events: 2 serious events

Other events: 101 other events

Deaths: 0 deaths

Vortioxetine 20 mg

Serious events: 0 serious events

Other events: 112 other events

Deaths: 0 deaths

Duloxetine 60 mg

Serious events: 0 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=159 participants at risk Placebo-matching capsules, orally, once daily for up to 9 weeks.	Vortioxetine 15 mg n=147 participants at risk Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Vortioxetine 20 mg n=154 participants at risk Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.	Duloxetine 60 mg n=150 participants at risk Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/159 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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.	0.68% 1/147 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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% 0/154 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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 Suicidal ideation	0.00% 0/159 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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.	0.68% 1/147 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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% 0/154 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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 • A treatment-emergent adverse event is defined as any event whose onset occurs or intensity increases after the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication. 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