Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
NCT03249376Phase 3Completed
- Lead sponsor
- Intra-Cellular Therapies, Inc. (Industry)
- Enrollment
- 381 (actual)
- Start date
- 27 Nov 2017
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019
- Last update posted
- 3 Jun 2022
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 2
Interventions
- Lumateperone Drug
- Placebo Other
Conditions and primary outcome
- Bipolar Depression
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03249376 (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
- Baseline to Day 43
- Measure
- Least squares mean
- Unit
- score on a scale
Lumateperone vs PlaceboSuperiority
- Estimate
- -4.6Least Squares Mean Difference
- 95% CI, two-sided
- -6.34 to -2.83
- 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 | 1 | 188 |
| Placebo | 0 | 189 |
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
3 on PubMedEfficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials.
CNS spectrums · 2025 Sep 29
PubMed 41017591 (opens in a new tab)DOI 10.1017/S1092852925100564 (opens in a new tab)
The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features.
The Journal of clinical psychiatry · 2023 Apr 24
PubMed 37103915 (opens in a new tab)DOI 10.4088/JCP.22m14739 (opens in a new tab)
Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial.
The American journal of psychiatry · 2021 Dec
PubMed 34551584 (opens in a new tab)DOI 10.1176/appi.ajp.2021.20091339 (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
- NCT03249376 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.