Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Public ClinicalTrials.gov record NCT06462586. 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 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Study identification
- NCT ID
- NCT06462586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 354 participants
Conditions and interventions
Conditions
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
- Jun 19, 2024 (Actual)
- Primary completion
- Feb 24, 2026 (Actual)
- Completion
- Mar 5, 2026 (Actual)
- Last update posted
- Jul 24, 2026
2024 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 8
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Rogers | Arkansas | 72758 | — |
| Clinical Site | Bellflower | California | 90706 | — |
| Clinical Site | Culver City | California | 90230 | — |
| Clinical Site | Garden Grove | California | 92845 | — |
| Clinical Site | Lemon Grove | California | 91945 | — |
| Clinical Site | Montclair | California | 91763 | — |
| Clinical Site | Hallandale | Florida | 33009 | — |
| Clinical Site | Hialeah | Florida | 33016 | — |
| Clinical Site | Miami | Florida | 33184 | — |
| Clinical Site | Miami Gardens | Florida | 33056 | — |
| Clinical Site | Miami Lakes | Florida | 33016 | — |
| Clinical Site | Miami Springs | Florida | 33166 | — |
| Clinical Site | Orlando | Florida | 32807 | — |
| Clinical Site | Atlanta | Georgia | 30324 | — |
| Clinical Site | Atlanta | Georgia | 30338 | — |
| Clinical Site | Decatur | Georgia | 30030 | — |
| Clinical Site | Savannah | Georgia | 31405 | — |
| Clinical Site | Shreveport | Louisiana | 71101 | — |
| Clinical Site | Marlton | New Jersey | 08053 | — |
| Clinical Site | North Canton | Ohio | 44720 | — |
| Clinical Site | Austin | Texas | 78701 | — |
| Clinical Site | Austin | Texas | 78754 | — |
| Clinical Site | DeSoto | Texas | 75115 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06462586, 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 Jul 24, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06462586 live on ClinicalTrials.gov.