Trial Outcomes & Findings for Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (NCT NCT04985942)
NCT ID: NCT04985942
Last Updated: 2025-05-02
Results Overview
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The 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
485 participants
Primary outcome timeframe
Day 43
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
Lumateperone 42 mg
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
243
|
|
Overall Study
COMPLETED
|
220
|
232
|
|
Overall Study
NOT COMPLETED
|
21
|
11
|
Reasons for withdrawal
| Measure |
Lumateperone 42 mg
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Lumateperone 42 mg
n=241 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=243 Participants
Placebo: Matching capsules administered orally, once daily.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 12.39 • n=99 Participants
|
45.1 years
STANDARD_DEVIATION 12.51 • n=107 Participants
|
45.0 years
STANDARD_DEVIATION 12.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
180 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
371 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
40 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=99 Participants
|
75 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
51 participants
n=99 Participants
|
54 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
21 participants
n=99 Participants
|
18 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
54 participants
n=99 Participants
|
55 participants
n=107 Participants
|
109 participants
n=206 Participants
|
|
Region of Enrollment
India
|
34 participants
n=99 Participants
|
31 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
30.4 units on a scale
STANDARD_DEVIATION 3.76 • n=99 Participants
|
30.0 units on a scale
STANDARD_DEVIATION 3.51 • n=107 Participants
|
30.2 units on a scale
STANDARD_DEVIATION 3.64 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: The analysis of the primary and secondary efficacy outcome measures are based on the Modified Intent-to-Treat (mITT) Population which included 481 randomized patients. The mITT Population includes all randomized patients who received at least 1 dose of study drug, had a baseline MADRS total score, and who had at least one on-study drug, postbaseline MADRS total score.
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The 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 42 mg
n=239 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=242 Participants
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale
|
-14.7 score on a scale
Standard Error 0.54
|
-9.8 score on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Day 43Change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S). The CGI-S 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 42 mg
n=239 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=242 Participants
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Clinical Global Impression Scale-Severity
|
-1.6 score on a scale
Standard Error 0.07
|
-0.9 score on a scale
Standard Error 0.07
|
Adverse Events
Lumateperone 42 mg
Serious events: 1 serious events
Other events: 92 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumateperone 42 mg
n=241 participants at risk
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=243 participants at risk
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.41%
1/241 • Number of events 1 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.00%
0/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.41%
1/243 • Number of events 1 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
Other adverse events
| Measure |
Lumateperone 42 mg
n=241 participants at risk
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=243 participants at risk
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
10.8%
26/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
2.1%
5/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
General disorders
Fatigue
|
9.5%
23/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
2.1%
5/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Tremor
|
5.0%
12/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.41%
1/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Headache
|
15.8%
38/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
15.2%
37/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
10.4%
25/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
6.2%
15/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
12/241 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
4.1%
10/243 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place