Trial Outcomes & Findings for Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (NCT NCT05061706)
NCT ID: NCT05061706
Last Updated: 2025-05-09
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
480 participants
Primary outcome timeframe
Day 43
Results posted on
2025-05-09
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
|
242
|
238
|
|
Overall Study
COMPLETED
|
205
|
224
|
|
Overall Study
NOT COMPLETED
|
37
|
14
|
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
|
29
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
Baseline Characteristics
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Lumateperone 42 mg
n=242 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=238 Participants
Placebo: Matching capsules administered orally, once daily.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.16 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 12.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
235 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
76 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
83 participants
n=5 Participants
|
78 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
30.8 units on a scale
STANDARD_DEVIATION 3.87 • n=5 Participants
|
31.5 units on a scale
STANDARD_DEVIATION 3.98 • n=7 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 3.94 • n=5 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 469 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=232 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=237 Participants
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale
|
-14.7 units on a scale
Standard Error 0.56
|
-10.2 units on a scale
Standard Error 0.54
|
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=232 Participants
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=237 Participants
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Clinical Global Impression Scale-Severity
|
-1.5 units on a scale
Standard Error 0.07
|
-1.0 units on a scale
Standard Error 0.07
|
Adverse Events
Lumateperone 42 mg
Serious events: 2 serious events
Other events: 138 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumateperone 42 mg
n=242 participants at risk
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=238 participants at risk
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.41%
1/242 • Number of events 1 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.00%
0/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Surgical and medical procedures
Polypectomy
|
0.41%
1/242 • Number of events 1 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.00%
0/238 • 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=242 participants at risk
Lumateperone: Lumateperone 42 mg capsules administered orally, once daily.
|
Placebo
n=238 participants at risk
Placebo: Matching capsules administered orally, once daily.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
22.3%
54/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
3.8%
9/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Somnolence
|
16.1%
39/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
2.9%
7/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
14.5%
35/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
4.6%
11/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
29/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
3.8%
9/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
13/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.84%
2/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
General disorders
Fatigue
|
5.0%
12/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
0.42%
1/238 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
|
Nervous system disorders
Headache
|
20.2%
49/242 • From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.
|
14.7%
35/238 • 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