Trial Outcomes & Findings for Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression (NCT NCT02600507)
NCT ID: NCT02600507
Last Updated: 2023-05-17
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
529 participants
Primary outcome timeframe
Baseline to Day 43
Results posted on
2023-05-17
Participant Flow
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
Lumateperone 28 mg
|
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 42
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
176
|
177
|
175
|
|
Overall Study
COMPLETED
|
147
|
133
|
150
|
|
Overall Study
NOT COMPLETED
|
29
|
44
|
25
|
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
Lumateperone 28 mg
|
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 42
|
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
15
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
2
|
|
Overall Study
Protocol Violation
|
12
|
4
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
11
|
7
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=176 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=177 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg
|
Placebo
n=175 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.56 • n=93 Participants
|
44.7 years
STANDARD_DEVIATION 12.60 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 12.93 • n=27 Participants
|
44.6 years
STANDARD_DEVIATION 13.02 • n=483 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
308 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
220 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
153 Participants
n=93 Participants
|
156 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
466 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
58 participants
n=4 Participants
|
56 participants
n=27 Participants
|
173 participants
n=483 Participants
|
|
Region of Enrollment
Ukraine
|
21 participants
n=93 Participants
|
21 participants
n=4 Participants
|
15 participants
n=27 Participants
|
57 participants
n=483 Participants
|
|
Region of Enrollment
Bulgaria
|
49 participants
n=93 Participants
|
45 participants
n=4 Participants
|
48 participants
n=27 Participants
|
142 participants
n=483 Participants
|
|
Region of Enrollment
Serbia
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
20 participants
n=27 Participants
|
52 participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
31 participants
n=93 Participants
|
37 participants
n=4 Participants
|
36 participants
n=27 Participants
|
104 participants
n=483 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
32.5 units on a scale
STANDARD_DEVIATION 5.55 • n=93 Participants
|
32.3 units on a scale
STANDARD_DEVIATION 4.96 • n=4 Participants
|
32.2 units on a scale
STANDARD_DEVIATION 5.23 • n=27 Participants
|
32.3 units on a scale
STANDARD_DEVIATION 5.24 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 43Population: Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and 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=171 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=174 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg
|
Placebo
n=174 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-16.2 score on a scale
Standard Error 0.79
|
-16.9 score on a scale
Standard Error 0.81
|
-14.5 score on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline to Day 43Population: Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score.
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).
Outcome measures
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=171 Participants
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=174 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg
|
Placebo
n=174 Participants
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
|
-1.7 score on a scale
Standard Error 0.09
|
-1.8 score on a scale
Standard Error 0.10
|
-1.5 score on a scale
Standard Error 0.09
|
Adverse Events
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=176 participants at risk
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=177 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg
|
Placebo
n=175 participants at risk
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/176 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
0.56%
1/177 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
0.00%
0/175 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
Other adverse events
| Measure |
Lumateperone 28 mg (ITI-007 40 mg Tosylate)
n=176 participants at risk
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 28 mg
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=177 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg
|
Placebo
n=175 participants at risk
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
13.1%
23/176 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
11.3%
20/177 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
11.4%
20/175 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Somnolence
|
7.4%
13/176 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
11.3%
20/177 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
3.4%
6/175 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
10.2%
18/176 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
10.7%
19/177 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
2.3%
4/175 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
10/176 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
8.5%
15/177 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
4.0%
7/175 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place