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Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

NCT06462586 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-07-01

No results posted yet for this 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

  • Bipolar Disorder, Manic

Interventions

DRUG

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily

DRUG

Placebo

Matching capsules administered orally, once daily

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • India
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462586 on ClinicalTrials.gov