Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06462586 · ClinicalTrials.gov registry record · Phase 3
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
A Phase 3 study of Bipolar Disorder, Manic, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT06462586 is a Phase 3 study of Bipolar Disorder, Manic that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 350 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT06462586, a Phase 3 study of Bipolar Disorder, Manic, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Hallandale
- Clinical Site - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami Gardens
- Clinical Site - Miami Lakes
- Clinical Site - Miami Springs
- Clinical Site - Orlando
California
- Clinical Site - Bellflower
- Clinical Site - Culver City
- Clinical Site - Garden Grove
- Clinical Site - Lemon Grove
- Clinical Site - Montclair
Georgia
- Clinical Site - Atlanta
- Clinical Site - Atlanta
- Clinical Site - Decatur
- Clinical Site - Savannah
Arkansas
- Clinical Site - Rogers
Louisiana
- Clinical Site - Shreveport
New Jersey
- Clinical Site - Marlton
Ohio
- Clinical Site - North Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-06-19 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06462586
The ClinicalTrials.gov registry entry for NCT06462586 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder, Manic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06462586 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06462586 about?
NCT06462586 is a clinical study titled "Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania". 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 ...
What is the current status of trial NCT06462586?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2024-06-19. Estimated completion is 2026-04.
What conditions does trial NCT06462586 study?
This clinical trial studies the following conditions: Bipolar Disorder, Manic.
What interventions are being tested in trial NCT06462586?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06462586?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06462586 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder, Manic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.