Trial Outcomes & Findings for Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder (NCT NCT04285515)
NCT ID: NCT04285515
Last Updated: 2025-03-19
Results Overview
The Montgomery-Åsberg Depression Rating Scale 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
488 participants
Primary outcome timeframe
Day 43
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Lumateperone 42mg
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
245
|
|
Overall Study
COMPLETED
|
211
|
217
|
|
Overall Study
NOT COMPLETED
|
32
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
Baseline characteristics by cohort
| Measure |
Lumateperone 42mg
n=240 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=241 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 14.54 • n=240 Participants
|
43.4 years
STANDARD_DEVIATION 13.89 • n=241 Participants
|
43.2 years
STANDARD_DEVIATION 14.21 • n=481 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=240 Participants
|
148 Participants
n=241 Participants
|
298 Participants
n=481 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=240 Participants
|
93 Participants
n=241 Participants
|
183 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
205 Participants
n=240 Participants
|
188 Participants
n=241 Participants
|
393 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
32 Participants
n=240 Participants
|
49 Participants
n=241 Participants
|
81 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=240 Participants
|
2 Participants
n=241 Participants
|
3 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=240 Participants
|
1 Participants
n=241 Participants
|
3 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
0 Participants
n=240 Participants
|
1 Participants
n=241 Participants
|
1 Participants
n=481 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=240 Participants
|
78 participants
n=241 Participants
|
160 participants
n=481 Participants
|
|
Region of Enrollment
Ukraine
|
20 participants
n=240 Participants
|
17 participants
n=241 Participants
|
37 participants
n=481 Participants
|
|
Region of Enrollment
Bulgaria
|
75 participants
n=240 Participants
|
92 participants
n=241 Participants
|
167 participants
n=481 Participants
|
|
Region of Enrollment
Serbia
|
15 participants
n=240 Participants
|
24 participants
n=241 Participants
|
39 participants
n=481 Participants
|
|
Region of Enrollment
Russia
|
48 participants
n=240 Participants
|
30 participants
n=241 Participants
|
78 participants
n=481 Participants
|
|
Montgomery-Asberg Depression Rating Scale
Combined MDD and Bipolar Depression Mixed Features Population
|
31.3 units on a scale
STANDARD_DEVIATION 4.05 • n=192 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.1 units on a scale
STANDARD_DEVIATION 4.07 • n=191 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.3 units on a scale
STANDARD_DEVIATION 4.06 • n=383 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
|
Montgomery-Asberg Depression Rating Scale
Bipolar Depression Mixed Features Population
|
31.8 units on a scale
STANDARD_DEVIATION 4.40 • n=100 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.1 units on a scale
STANDARD_DEVIATION 4.01 • n=99 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.5 units on a scale
STANDARD_DEVIATION 4.22 • n=199 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
|
Montgomery-Asberg Depression Rating Scale
MDD Mixed Features Population
|
30.8 units on a scale
STANDARD_DEVIATION 3.59 • n=92 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.2 units on a scale
STANDARD_DEVIATION 4.16 • n=92 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.0 units on a scale
STANDARD_DEVIATION 3.88 • n=184 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
|
Montgomery-Asberg Depression Rating Scale
Overall Population
|
31.3 units on a scale
STANDARD_DEVIATION 4.33 • n=239 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.4 units on a scale
STANDARD_DEVIATION 4.36 • n=238 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
31.3 units on a scale
STANDARD_DEVIATION 4.34 • n=477 Participants • Numbers analyzed below represent all patients who received at least 1 dose of study drug and who had a nonmissing (predose) baseline assessment and at least 1 nonmissing postbaseline assessment of MADRS total score in the respective population.
|
PRIMARY outcome
Timeframe: Day 43Population: Combined MDD and Bipolar Depression Mixed Features Population
The Montgomery-Åsberg Depression Rating Scale 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 42mg
n=192 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=191 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-18.1 score on a scale
Standard Error 0.71
|
-12.4 score on a scale
Standard Error 0.70
|
PRIMARY outcome
Timeframe: Day 43Population: Bipolar Depression Mixed Features Population
The Montgomery-Åsberg Depression Rating Scale 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 42mg
n=100 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=99 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-17.7 score on a scale
Standard Error 1.00
|
-12.0 score on a scale
Standard Error 0.96
|
PRIMARY outcome
Timeframe: Day 43Population: MDD Mixed Features Population
The Montgomery-Åsberg Depression Rating Scale 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 42mg
n=92 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=92 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-18.2 score on a scale
Standard Error 0.95
|
-12.2 score on a scale
Standard Error 0.96
|
PRIMARY outcome
Timeframe: Day 43Population: Overall Population
The Montgomery-Åsberg Depression Rating Scale 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 42mg
n=239 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=238 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-17.7 score on a scale
Standard Error 0.64
|
-12.1 score on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Day 43Population: Combined MDD and Bipolar Depression Mixed Features Population
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Lumateperone 42mg
n=192 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=191 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
|
-1.8 score on a scale
Standard Error 0.08
|
-1.2 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Day 43Population: Bipolar Depression Mixed Features Population
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Lumateperone 42mg
n=100 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=99 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
|
-1.8 score on a scale
Standard Error 0.11
|
-1.2 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 43Population: MDD Mixed Features Population
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Lumateperone 42mg
n=92 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=92 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
|
-1.7 score on a scale
Standard Error 0.11
|
-1.1 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 43Population: Overall Population
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Lumateperone 42mg
n=239 Participants
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=238 Participants
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
|
-1.7 score on a scale
Standard Error 0.07
|
-1.1 score on a scale
Standard Error 0.07
|
Adverse Events
Lumateperone 42mg
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumateperone 42mg
n=240 participants at risk
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=241 participants at risk
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/240 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
0.41%
1/241 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
Other adverse events
| Measure |
Lumateperone 42mg
n=240 participants at risk
Lumateperone 42mg administered once daily in the evening
Lumateperone: Lumateperone 42mg oral capsule
|
Placebo
n=241 participants at risk
Matching placebo administered once daily in the evening
Placebos: Placebo oral capsule
|
|---|---|---|
|
Nervous system disorders
Headache
|
15.4%
37/240 • Number of events 37 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
12.4%
30/241 • Number of events 30 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Somnolence
|
12.9%
31/240 • Number of events 31 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
1.7%
4/241 • Number of events 4 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
11.7%
28/240 • Number of events 28 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
1.7%
4/241 • Number of events 4 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
19/240 • Number of events 19 • From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
|
2.1%
5/241 • Number of events 5 • 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