Trial · NCT04985942

Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT04985942, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2025-05-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder. Trials, record NCT04985942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04985942

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT number: NCT04985942
Status: Completed
Phases: Phase 3
Enrollment: 485 participants, actual
Lead sponsor: Intra-Cellular Therapies, Inc.
Conditions: Major Depressive Disorder
Interventions: Lumateperone, Placebo
First posted: 2021-08-02
Last updated: 2025-05-02
Results first posted: 2025-05-02

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Montgomery-Åsberg Depression Rating Scale	Day 43	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.
Secondary	Clinical Global Impression Scale-Severity	Day 43	Change 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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Montgomery-Åsberg Depression Rating Scale	Day 43	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression Scale-Severity	Day 43		score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Montgomery-Åsberg Depression Rating Scale	Lumateperone 42 mg	-14.7	Standard Error 0.54	score on a scale
Montgomery-Åsberg Depression Rating Scale	Placebo	-9.8	Standard Error 0.53	score on a scale
Clinical Global Impression Scale-Severity	Lumateperone 42 mg	-1.6	Standard Error 0.07	score on a scale
Clinical Global Impression Scale-Severity	Placebo	-0.9	Standard Error 0.07	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lumateperone 42 mg	241
Overall Study	STARTED	Placebo	243
Overall Study	COMPLETED	Lumateperone 42 mg	220
Overall Study	COMPLETED	Placebo	232
Overall Study	NOT COMPLETED	Lumateperone 42 mg	21
Overall Study	NOT COMPLETED	Placebo	11

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dry Mouth	Gastrointestinal disorders	Lumateperone 42 mg	26	241
other	Dry Mouth	Gastrointestinal disorders	Placebo	5	243
other	Fatigue	General disorders	Lumateperone 42 mg	23	241
other	Fatigue	General disorders	Placebo	5	243
other	Tremor	Nervous system disorders	Lumateperone 42 mg	12	241
other	Tremor	Nervous system disorders	Placebo	1	243
other	Headache	Nervous system disorders	Lumateperone 42 mg	38	241
other	Headache	Nervous system disorders	Placebo	37	243
other	Dizziness	Nervous system disorders	Lumateperone 42 mg	25	241
other	Dizziness	Nervous system disorders	Placebo	15	243

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lumateperone 42 mg	0	241
Total, all-cause mortality	Placebo	0	243
Total, other adverse events	Lumateperone 42 mg	92	241
Total, other adverse events	Placebo	53	243
Total, serious adverse events	Lumateperone 42 mg	1	241
Total, serious adverse events	Placebo	1	243

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40875502	DERIVED	PubMed
42455478	DERIVED	PubMed
42752587	DERIVED	PubMed
42987117	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lumateperone 42 mg vs Placebo: deaths from any cause	Trial comparisons
Lumateperone 42 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04985942

GET https://conductscience.org/api/trials/v1/NCT04985942/registered

API reference For AI assistants