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

NCT05850689Phase 3Recruiting

Lead sponsor
Intra-Cellular Therapies, Inc. (Industry)
Enrollment
470 (estimated)
Start date
2 May 2023
Primary completion
5 Apr 2027 (estimated)
Study completion
5 Apr 2027
Last update posted
25 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Triple
Arms
2

Interventions

  • Lumateperone Drug
  • Placebo Drug

Conditions and primary outcome

  • Major Depressive Disorder

Primary outcome

Montgomery-Asberg Depression Rating Scale (Day 43)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT05850689.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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