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

Conditions

• Bipolar Disorder, Manic

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Lumateperone — DRUG
  Lumateperone 42 mg capsules administered orally, once daily
• Placebo — DRUG
  Matching capsules administered orally, once daily

Study Details

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).

Key Dates

Start date

Jun 19, 2024

Status verified

Jun 2025

Primary completion

Mar 31, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lumateperone 42 mg
  Lumateperone 42 mg capsules
• Placebo Comparator: Placebo
  Matching placebo

Primary Outcome Measure

Young Mania Rating Scale (YMRS) [ Time Frame: Week 3 ]

Central Contacts

• ITI Clinical Trials
  (646) 440-9333
  [email protected]

Locations (23)

Find similar trials in Rogers, AR

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