Trial Outcomes & Findings for Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally (NCT NCT03249376)

NCT ID: NCT03249376

Last Updated: 2022-06-03

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: 381 participants
• Primary outcome timeframe: Baseline to Day 43
• Results posted on: 2022-06-03

Participant Flow

Participant milestones

Measure	Lumateperone Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone (ITI-007 60 mg tosylate)	Placebo Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Overall Study STARTED	188	189
Overall Study COMPLETED	167	166
Overall Study NOT COMPLETED	21	23

Reasons for withdrawal

Measure	Lumateperone Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone (ITI-007 60 mg tosylate)	Placebo Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Overall Study Adverse Event	11	5
Overall Study Lack of Efficacy	2	4
Overall Study Protocol Violation	3	2
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	3	9
Overall Study LTFU	2	1

Baseline Characteristics

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Baseline characteristics by cohort

Measure	Lumateperone n=188 Participants Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=189 Participants Placebo administered once daily every evening for 6 weeks Placebo: Placebo	Total n=377 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 14.09 • n=5 Participants	44.1 years STANDARD_DEVIATION 12.87 • n=7 Participants	44.9 years STANDARD_DEVIATION 13.50 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	120 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	69 Participants n=7 Participants	158 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	173 Participants n=5 Participants	171 Participants n=7 Participants	344 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	59 participants n=7 Participants	110 participants n=5 Participants
Region of Enrollment Ukraine	49 participants n=5 Participants	38 participants n=7 Participants	87 participants n=5 Participants
Region of Enrollment Bulgaria	49 participants n=5 Participants	43 participants n=7 Participants	92 participants n=5 Participants
Region of Enrollment Serbia	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Russia	32 participants n=5 Participants	34 participants n=7 Participants	66 participants n=5 Participants
Region of Enrollment Colombia	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	30.8 units on a scale STANDARD_DEVIATION 4.92 • n=5 Participants	30.2 units on a scale STANDARD_DEVIATION 4.65 • n=7 Participants	30.5 units on a scale STANDARD_DEVIATION 4.79 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 43

Population: 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 n=188 Participants Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=188 Participants Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-16.70 score on a scale Standard Error 0.693	-12.12 score on a scale Standard Error 0.677

SECONDARY outcome

Timeframe: Baseline to Day 43

Population: 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 (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.

Outcome measures

Measure	Lumateperone n=188 Participants Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=188 Participants Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score	-3.48 score on a scale Standard Error 0.170	-2.54 score on a scale Standard Error 0.167

SECONDARY outcome

Timeframe: Baseline to Day 43

Population: 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 Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.

Outcome measures

Measure	Lumateperone n=188 Participants Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=188 Participants Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score	19.4 Percent Score Standard Error 1.49	14.9 Percent Score Standard Error 1.45

Adverse Events

Lumateperone

Serious events: 1 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lumateperone n=188 participants at risk Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=189 participants at risk Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Psychiatric disorders Mania	0.53% 1/188 • Number of events 1 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.	0.00% 0/189 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.

Other adverse events

Measure	Lumateperone n=188 participants at risk Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)	Placebo n=189 participants at risk Placebo administered once daily every evening for 6 weeks Placebo: Placebo
Nervous system disorders Headache	17.6% 33/188 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.	10.1% 19/189 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
Nervous system disorders Somnolence	8.5% 16/188 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.	1.1% 2/189 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
Gastrointestinal disorders Nauseau	6.4% 12/188 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.	2.1% 4/189 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
Nervous system disorders Dizziness	4.8% 9/188 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.	5.3% 10/189 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.

Additional Information

ITI Clinical Trials

Intra-Cellular Therapies, Inc.

Phone: 646-440-9333

Email: ITCIClinicalTrials@itci-inc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place