An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05061719Phase 3Completed
- Lead sponsor
- Intra-Cellular Therapies, Inc. (Industry)
- Enrollment
- 812 (actual)
- Start date
- 8 Oct 2021
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 23 Oct 2024
- Last update posted
- 3 Nov 2025
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Lumateperone Drug
Conditions and primary outcome
- Major Depressive Disorder
Primary outcome
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events (26 weeks)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT05061719 (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
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
| Group | Affected | At risk |
|---|---|---|
| Lumateperone 42 mg | 8 | 809 |
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
No PubMed citation lists NCT05061719.
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
- NCT05061719 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.