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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: Recruiting Phase 3 study of Bipolar Disorder, Manic, sponsored by Intra-Cellular Therapies.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
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 |
What NCT06462612 shows while recruiting
NCT06462612 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
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 names 20 study sites across 7 states, led by 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.
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.
Where NCT06462612's enrollment target sits among peer trials
350 1035th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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