Trial Outcomes & Findings for Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder (NCT NCT01469377)

Last Updated: 2018-05-01

Results Overview

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

819 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2018-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Overall Study STARTED	269	274	276
Overall Study COMPLETED	234	226	210
Overall Study NOT COMPLETED	35	48	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Overall Study Protocol Deviation	7	10	10
Overall Study Lost to Follow-up	3	2	5
Overall Study Withdrawal of Consent	12	14	15
Overall Study Adverse Event	8	18	36
Overall Study Insufficient Therapeutic Response	3	4	0
Overall Study Other Miscellaneous Reasons	2	0	0

Baseline Characteristics

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=266 Participants Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg n=273 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg n=273 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Total n=812 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 11.6 • n=5 Participants	45.5 years STANDARD_DEVIATION 11.9 • n=7 Participants	45.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	45.7 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	187 Participants n=7 Participants	201 Participants n=5 Participants	578 Participants n=4 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	86 Participants n=7 Participants	72 Participants n=5 Participants	234 Participants n=4 Participants
Race/Ethnicity, Customized White	230 participants n=5 Participants	234 participants n=7 Participants	242 participants n=5 Participants	706 participants n=4 Participants
Race/Ethnicity, Customized All other races	36 participants n=5 Participants	39 participants n=7 Participants	31 participants n=5 Participants	106 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	32 participants n=5 Participants	31 participants n=7 Participants	24 participants n=5 Participants	87 participants n=4 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	9 participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	14 participants n=5 Participants	17 participants n=7 Participants	22 participants n=5 Participants	53 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	252 participants n=5 Participants	256 participants n=7 Participants	251 participants n=5 Participants	759 participants n=4 Participants
Weight	81.53 kg STANDARD_DEVIATION 16.19 • n=5 Participants	79.69 kg STANDARD_DEVIATION 16.31 • n=7 Participants	82.17 kg STANDARD_DEVIATION 17.37 • n=5 Participants	81.13 kg STANDARD_DEVIATION 16.65 • n=4 Participants
Body Mass Index (BMI)	28.93 kg/m^2 STANDARD_DEVIATION 5.09 • n=5 Participants	28.21 kg/m^2 STANDARD_DEVIATION 5.51 • n=7 Participants	29.05 kg/m^2 STANDARD_DEVIATION 5.59 • n=5 Participants	28.73 kg/m^2 STANDARD_DEVIATION 5.41 • n=4 Participants
Waist Circumference	94.32 cm STANDARD_DEVIATION 13.44 • n=5 Participants	93.36 cm STANDARD_DEVIATION 14.20 • n=7 Participants	94.91 cm STANDARD_DEVIATION 14.66 • n=5 Participants	94.20 cm STANDARD_DEVIATION 14.12 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score.

Outcome measures

Outcome measures
Measure	Placebo n=264 Participants Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg n=273 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg n=271 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	-12.5 Units on a scale Standard Error 0.5	-13.4 Units on a scale Standard Error 0.5	-14.6 Units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score. Only participants with scores for all 3 domains were included in the analysis.

The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=264 Participants Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg n=273 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg n=271 Participants Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8	-6.6 Units on a scale Standard Error 0.5	-7.7 Units on a scale Standard Error 0.5	-8.0 Units on a scale Standard Error 0.5

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 102 other events

Deaths: 0 deaths

Cariprazine 1-2 mg

Serious events: 0 serious events

Other events: 121 other events

Deaths: 0 deaths

Cariprazine 2-4.5 mg

Serious events: 3 serious events

Other events: 179 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=266 participants at risk Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg n=273 participants at risk Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg n=273 participants at risk Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
General disorders Non-cardiac chest pain	0.00% 0/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.37% 1/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Psychiatric disorders Agitation	0.00% 0/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.37% 1/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Psychiatric disorders Panic attack	0.00% 0/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.37% 1/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Psychiatric disorders Depression	0.38% 1/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.37% 1/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Cardiac disorders Myocardial ischemia	0.00% 0/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.00% 0/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	0.37% 1/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.

Other adverse events

Other adverse events
Measure	Placebo n=266 participants at risk Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 1-2 mg n=273 participants at risk Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.	Cariprazine 2-4.5 mg n=273 participants at risk Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Gastrointestinal disorders Constipation	1.9% 5/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	2.2% 6/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	5.1% 14/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Gastrointestinal disorders Diarrhoea	5.3% 14/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	2.9% 8/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	2.9% 8/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Gastrointestinal disorders Dry mouth	2.6% 7/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	5.1% 14/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	3.7% 10/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Gastrointestinal disorders Nausea	4.9% 13/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	7.0% 19/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	12.8% 35/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
General disorders Fatigue	4.1% 11/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	6.6% 18/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	9.9% 27/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Metabolism and nutrition disorders Increased appetite	1.5% 4/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	1.8% 5/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	5.1% 14/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Nervous system disorders Akathisia	2.3% 6/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	6.6% 18/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	22.3% 61/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Nervous system disorders Dizziness	2.6% 7/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	3.7% 10/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	5.1% 14/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Nervous system disorders Headache	13.5% 36/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	8.8% 24/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	8.8% 24/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Nervous system disorders Somnolence	5.3% 14/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	8.8% 24/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	9.9% 27/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Nervous system disorders Tremor	1.5% 4/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	4.8% 13/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	7.7% 21/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Psychiatric disorders Insomnia	6.4% 17/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	9.9% 27/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	13.9% 38/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.
Psychiatric disorders Restlessness	2.6% 7/266 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	8.1% 22/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.	8.4% 23/273 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who received at least 1 dose of treatment.

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Publication restrictions are in place

Restriction type: OTHER