Trial · NCT04285515
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
NCT04285515, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2025-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder. Trials, record NCT04285515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04285515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
- NCT number
- NCT04285515
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 488 participants, actual
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Conditions
- Bipolar Depression, Major Depressive Disorder
- Interventions
- Lumateperone, Placebos
- First posted
- 2020-02-26
- Last updated
- 2025-03-19
- Results first posted
- 2025-03-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 43 | 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. |
| Secondary | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Day 43 | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 43 | Combined MDD and Bipolar Depression Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 43 | Bipolar Depression Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 43 | MDD Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 43 | Overall Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Day 43 | Combined MDD and Bipolar Depression Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Day 43 | Bipolar Depression Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Day 43 | MDD Mixed Features Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Day 43 | Overall Population | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42mg | -18.1 | Standard Error 0.71 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -12.4 | Standard Error 0.70 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42mg | -17.7 | Standard Error 1.00 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -12.0 | Standard Error 0.96 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42mg | -18.2 | Standard Error 0.95 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -12.2 | Standard Error 0.96 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42mg | -17.7 | Standard Error 0.64 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -12.1 | Standard Error 0.63 | score on a scale | |
| Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Lumateperone 42mg | -1.8 | Standard Error 0.08 | score on a scale | |
| Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) | Placebo | -1.2 | Standard Error 0.08 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lumateperone 42mg | 243 | |
| Overall Study | STARTED | Placebo | 245 | |
| Overall Study | COMPLETED | Lumateperone 42mg | 211 | |
| Overall Study | COMPLETED | Placebo | 217 | |
| Overall Study | NOT COMPLETED | Lumateperone 42mg | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 28 |
Source ClinicalTrials.gov
Adverse events10
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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Lumateperone 42mg | 37 | 240 | 37 |
| other | Headache | Nervous system disorders | Placebo | 30 | 241 | 30 |
| other | Somnolence | Nervous system disorders | Lumateperone 42mg | 31 | 240 | 31 |
| other | Somnolence | Nervous system disorders | Placebo | 4 | 241 | 4 |
| other | Dizziness | Nervous system disorders | Lumateperone 42mg | 28 | 240 | 28 |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 241 | 4 |
| other | Nausea | Gastrointestinal disorders | Lumateperone 42mg | 19 | 240 | 19 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 241 | 5 |
| serious | Dermatitis | Skin and subcutaneous tissue disorders | Lumateperone 42mg | 0 | 240 | |
| serious | Dermatitis | Skin and subcutaneous tissue disorders | Placebo | 1 | 241 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lumateperone 42mg | 0 | 240 |
| Total, all-cause mortality | Placebo | 0 | 241 |
| Total, other adverse events | Lumateperone 42mg | 84 | 240 |
| Total, other adverse events | Placebo | 37 | 241 |
| Total, serious adverse events | Lumateperone 42mg | 0 | 240 |
| Total, serious adverse events | Placebo | 1 | 241 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39946099 | DERIVED |
Source 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 42mg vs Placebo: deaths from any cause | Trial comparisons |
| Lumateperone 42mg 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.
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/NCT04285515
GET https://conductscience.org/api/trials/v1/NCT04285515/registered