Trial Outcomes & Findings for Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression (NCT NCT02600494)
NCT ID: NCT02600494
Last Updated: 2025-11-03
Results Overview
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
554 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-11-03
Participant Flow
Part A includes all patients who signed the informed consent and were randomized in to the 6 week double-blind treatment period. 554 patients were randomized; 549 patients received study drug and are included in the safety population. Part B includes all patients who signed the informed consent and received open-label study drug for up to 6 months.
Participant milestones
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Part A (6 Week Double-Blind Treatment)
STARTED
|
183
|
185
|
186
|
|
Part A (6 Week Double-Blind Treatment)
Number of Patients Randomized and Took at Least 1 Dose of Study Drug
|
180
|
184
|
185
|
|
Part A (6 Week Double-Blind Treatment)
COMPLETED
|
126
|
113
|
138
|
|
Part A (6 Week Double-Blind Treatment)
NOT COMPLETED
|
57
|
72
|
48
|
|
Part B (6 Month Open-Label Treatment)
STARTED
|
0
|
127
|
0
|
|
Part B (6 Month Open-Label Treatment)
COMPLETED
|
0
|
74
|
0
|
|
Part B (6 Month Open-Label Treatment)
NOT COMPLETED
|
0
|
53
|
0
|
Reasons for withdrawal
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Part A (6 Week Double-Blind Treatment)
Physician Decision
|
2
|
3
|
4
|
|
Part A (6 Week Double-Blind Treatment)
Adverse Event
|
13
|
15
|
4
|
|
Part A (6 Week Double-Blind Treatment)
Lack of Efficacy
|
2
|
4
|
2
|
|
Part A (6 Week Double-Blind Treatment)
Protocol Violation
|
13
|
10
|
14
|
|
Part A (6 Week Double-Blind Treatment)
Withdrawal by Subject
|
15
|
11
|
14
|
|
Part A (6 Week Double-Blind Treatment)
Lost to Follow-up
|
12
|
28
|
10
|
|
Part A (6 Week Double-Blind Treatment)
non-compliant with site request
|
0
|
1
|
0
|
|
Part B (6 Month Open-Label Treatment)
Adverse Event
|
0
|
12
|
0
|
|
Part B (6 Month Open-Label Treatment)
Lack of Efficacy
|
0
|
4
|
0
|
|
Part B (6 Month Open-Label Treatment)
Protocol Violation
|
0
|
8
|
0
|
|
Part B (6 Month Open-Label Treatment)
Physician Decision
|
0
|
1
|
0
|
|
Part B (6 Month Open-Label Treatment)
Withdrawal by Subject
|
0
|
17
|
0
|
|
Part B (6 Month Open-Label Treatment)
Lost to Follow-up
|
0
|
11
|
0
|
Baseline Characteristics
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=184 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
n=185 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
Total
n=549 Participants
Total of all reporting groups
|
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=180 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
111 Participants
n=15 Participants
|
114 Participants
n=18 Participants
|
334 Participants
n=4 Participants
|
109 Participants
n=3 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 11.85 • n=15 Participants
|
42.3 years
STANDARD_DEVIATION 13.13 • n=18 Participants
|
41.9 years
STANDARD_DEVIATION 12.40 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 12.12 • n=3 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=15 Participants
|
71 Participants
n=18 Participants
|
215 Participants
n=4 Participants
|
71 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
106 participants
n=15 Participants
|
98 participants
n=18 Participants
|
304 participants
n=4 Participants
|
100 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
72 participants
n=15 Participants
|
80 participants
n=18 Participants
|
227 participants
n=4 Participants
|
75 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=15 Participants
|
3 participants
n=18 Participants
|
6 participants
n=4 Participants
|
1 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=15 Participants
|
1 participants
n=18 Participants
|
3 participants
n=4 Participants
|
0 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=15 Participants
|
1 participants
n=18 Participants
|
2 participants
n=4 Participants
|
0 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=15 Participants
|
1 participants
n=18 Participants
|
6 participants
n=4 Participants
|
4 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=15 Participants
|
1 participants
n=18 Participants
|
1 participants
n=4 Participants
|
0 participants
n=3 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
35.9 units on a scale
STANDARD_DEVIATION 5.79 • n=15 Participants
|
34.7 units on a scale
STANDARD_DEVIATION 5.84 • n=18 Participants
|
35.4 units on a scale
STANDARD_DEVIATION 5.92 • n=4 Participants
|
35.8 units on a scale
STANDARD_DEVIATION 6.08 • n=3 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and who had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score.
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Outcome measures
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=172 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=166 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
n=177 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-18.9 score on a scale
Standard Error 1.11
|
-20.7 score on a scale
Standard Error 1.16
|
-19.7 score on a scale
Standard Error 1.11
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=172 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=166 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
n=177 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Time to First Sustained Response in Reduction of MADRS Total Score
|
43 days
Interval 36.0 to
Upper limit of the confidence interval could not be calculated due to insufficient number of events.
|
38 days
Interval 36.0 to
Upper limit of the confidence interval could not be calculated due to insufficient number of events.
|
37 days
Interval 30.0 to
Upper limit of the confidence interval could not be calculated due to insufficient number of events.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 175Population: Safety Analysis Set - all patients who received at least 1 dose of study medication in Part B
The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)
Outcome measures
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=127 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-8.9 units on a scale
Standard Deviation 10.76
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 175Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)
Outcome measures
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=127 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Adverse Events
Somnolence
|
11 Participants
|
—
|
—
|
|
Adverse Events
Anxiety
|
10 Participants
|
—
|
—
|
|
Adverse Events
Irritability
|
8 Participants
|
—
|
—
|
|
Adverse Events
Headache
|
26 Participants
|
—
|
—
|
|
Adverse Events
Dry Mouth
|
15 Participants
|
—
|
—
|
|
Adverse Events
Dizziness
|
13 Participants
|
—
|
—
|
|
Adverse Events
Nausea
|
13 Participants
|
—
|
—
|
Adverse Events
Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Serious events: 4 serious events
Other events: 55 other events
Deaths: 0 deaths
Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate)
Serious events: 5 serious events
Other events: 72 other events
Deaths: 0 deaths
Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Part A Placebo
Serious events: 1 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=127 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for up to 6 months
Lumateperone (ITI-007)
|
Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=180 participants at risk
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=184 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Part A Placebo
n=185 participants at risk
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.79%
1/127 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Mania
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Suicidal Ideation
|
0.79%
1/127 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Agression
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.54%
1/185 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Injury, poisoning and procedural complications
Procedural hemorrhage
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Mental status changes
|
0.79%
1/127 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Gastrointestinal disorders
colitis ulcerative
|
0.79%
1/127 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
Other adverse events
| Measure |
Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=127 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for up to 6 months
Lumateperone (ITI-007)
|
Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=180 participants at risk
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
ITI-007 (Lumateperone)
|
Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=184 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
|
Part A Placebo
n=185 participants at risk
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
11.8%
15/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
7.2%
13/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
8.2%
15/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.6%
3/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Nervous system disorders
Dizziness
|
10.2%
13/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
5.6%
10/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
8.2%
15/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
2.2%
4/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
4/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
5.0%
9/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
5.4%
10/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
2.7%
5/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
6/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
2.8%
5/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
5.4%
10/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.00%
0/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
General disorders
Fatigue
|
3.1%
4/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
6.1%
11/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
2.2%
4/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.6%
3/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Anxiety
|
7.9%
10/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.56%
1/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.1%
2/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.6%
3/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Psychiatric disorders
Irritability
|
6.3%
8/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.7%
3/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
1.6%
3/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
0.54%
1/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Nervous system disorders
Somnolence
|
8.7%
11/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
11.7%
21/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
13.0%
24/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
3.8%
7/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Nervous system disorders
Headache
|
20.5%
26/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
19.4%
35/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
10.9%
20/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
5.4%
10/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
|
Gastrointestinal disorders
Nausea
|
10.2%
13/127 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
6.7%
12/180 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
8.7%
16/184 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
3.8%
7/185 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment
|
Additional Information
Vice President, Clinical Development
Intra-Cellular Therapies, Inc.
Phone: 646-440-9333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place