Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Public ClinicalTrials.gov record NCT04285515. 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder
Study identification
- NCT ID
- NCT04285515
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Industry
- Enrollment
- 488 participants
Conditions and interventions
Conditions
Interventions
- Lumateperone Drug
- Placebos Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Feb 26, 2020
- Primary completion
- Nov 29, 2022
- Completion
- Nov 29, 2022
- Last update posted
- Mar 18, 2025
2020 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Garden Grove | California | 92845 | — |
| Clinical Site | Oceanside | California | 92056 | — |
| Clinical Site | Sherman Oaks | California | 91403 | — |
| Clinical Site | Lauderhill | Florida | 33319 | — |
| Clinical Site | Miami | Florida | 33122 | — |
| Clinical Site | Orange City | Florida | 32763 | — |
| Clinical Site | Atlanta | Georgia | 30331 | — |
| Clinical Site | Decatur | Georgia | 30030 | — |
| Clinical Site | O'Fallon | Missouri | 63368 | — |
| Clinical Site | Cedarhurst | New York | 11694 | — |
| Clinical Site | New York | New York | 10128 | — |
| Clinical Site | Charlotte | North Carolina | 28211 | — |
| Clinical Site | Bellevue | Washington | 98007 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04285515, 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 Mar 18, 2025 · Synced May 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04285515 live on ClinicalTrials.gov.