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NCT06462612 · ClinicalTrials.gov registry record · Phase 3
Study of Lumateperone in the 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
NCT06462612 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
NCT06462612, 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 - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami Lakes
- Clinical Site - Miami Lakes
- Clinical Site - Tampa
- Clinical Site - West Palm Beach
California
- Clinical Site - Anaheim
- Clinical Site - Cerritos
- Clinical Site - Orange
- Clinical Site - Torrance
Arkansas
- Clinical Site - Bentonville
- Clinical Site - Little Rock
Georgia
- Clinical Site - Atlanta
- Clinical Site - Stockbridge
Illinois
- Clinical Site - Chicago
- Clinical Site - Chicago
Maryland
- Clinical Site - Gaithersburg
New York
- Clinical Site - Glen Oaks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-07-17 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06462612
The ClinicalTrials.gov registry entry for NCT06462612 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.
NCT06462612 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06462612 about?
NCT06462612 is a clinical study titled "Study of Lumateperone in the 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 NCT06462612?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2024-07-17. Estimated completion is 2026-06.
What conditions does trial NCT06462612 study?
This clinical trial studies the following conditions: Bipolar Disorder, Manic.
What interventions are being tested in trial NCT06462612?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06462612?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06462612 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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