Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
NCT04285515Phase 3Completed
- Lead sponsor
- Intra-Cellular Therapies, Inc. (Industry)
- Enrollment
- 488 (actual)
- Start date
- 27 Feb 2020
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022
- Last update posted
- 19 Mar 2025
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 2
Interventions
- Lumateperone Drug
- Placebos Drug
Conditions and primary outcome
- Bipolar Depression
- Major Depressive Disorder
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Day 43)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04285515 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Time frame
- Day 43
- Measure
- Least squares mean
- Unit
- score on a scale
Lumateperone 42mg vs PlaceboSuperiority
- Estimate
- -5.7Least Squares Mean Difference
- 95% CI, two-sided
- -7.60 to -3.84
- p-value
- <0.0001
- Method
- Mixed Effects Model for Repeated Measure
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Time frame
- Day 43
- Measure
- Least squares mean
- Unit
- score on a scale
Lumateperone 42mg vs PlaceboSuperiority
- Estimate
- -5.7Least Squares Mean Difference
- 95% CI, two-sided
- -8.29 to -3.05
- p-value
- <0.0001
- Method
- Mixed Effects Model for Repeated Measure
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Time frame
- Day 43
- Measure
- Least squares mean
- Unit
- score on a scale
Lumateperone 42mg vs PlaceboSuperiority
- Estimate
- -5.9Least Squares Mean Difference
- 95% CI, two-sided
- -8.61 to -3.29
- p-value
- <0.0001
- Method
- Mixed Effects Model for Repeated Measure
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Time frame
- Day 43
- Measure
- Least squares mean
- Unit
- score on a scale
Lumateperone 42mg vs PlaceboSuperiority
- Estimate
- -5.6Least Squares Mean Difference
- 95% CI, two-sided
- -7.25 to -3.88
- p-value
- <0.0001
- Method
- Mixed Effects Model for Repeated Measure
Serious adverse events
Time frame: From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
| Group | Affected | At risk |
|---|---|---|
| Lumateperone 42mg | 0 | 240 |
| Placebo | 1 | 241 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedLumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial.
Journal of clinical psychopharmacology · 2025 Mar-Apr 01
PubMed 39946099 (opens in a new tab)DOI 10.1097/JCP.0000000000001964 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04285515 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.