Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Public ClinicalTrials.gov record NCT04985942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Study identification
- NCT ID
- NCT04985942
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2021
- Primary completion
- Feb 21, 2024
- Completion
- Feb 26, 2024
- Last update posted
- May 1, 2025
2021 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Phoenix | Arizona | 85012 | — |
| Clinical Site | Glendale | California | 91206 | — |
| Clinical Site | Oceanside | California | 92056 | — |
| Clinical Site | Redlands | California | 92374 | — |
| Clinical Site | Temecula | California | 92591 | — |
| Clinical Site | Upland | California | 91786 | — |
| Clinical Site | Fort Lauderdale | Florida | 33319 | — |
| Clinical Site | Jacksonville | Florida | 32256 | — |
| Clinical Site | Orlando | Florida | 32801 | — |
| Clinical Site | Decatur | Georgia | 30030 | — |
| Clinical Site | Boston | Massachusetts | 02131 | — |
| Clinical Site | Berlin | New Jersey | 08009 | — |
| Clinical Site | Toms River | New Jersey | 08755 | — |
| Clinical Site | Cedarhurst | New York | 11516 | — |
| Clinical Site | Austin | Texas | 78737 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04985942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04985942 live on ClinicalTrials.gov.