NCT06462612

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be conducted in 3 phases: * Screening Period (up to 1 week) during which patient eligibility will be assessed. * Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio. * Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Conditions

• Bipolar Disorder, Manic

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 42 mg capsules administered orally, once daily
DRUG	Placebo	Matching capsules administered orally, once daily

Timeline

• Start date: 2024-07-17
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2024-06-17
• Last updated: 2025-07-01

Locations

35 sites across 4 countries: United States, Bulgaria, Romania, Serbia

Regulatory

• FDA-regulated drug study