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

NCT06462586 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ITI-007-451
• Study Type: interventional
• Target: 350
• Locations: 5 countries
• Sites: 42

Brief 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

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  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.

  Week 3

Secondary Outcomes (1)

• Clinical Global Impression Scale-Severity (CGI-S)

  Week 3

Study Arms (2)

Lumateperone 42 mg

EXPERIMENTAL

Lumateperone 42 mg capsules

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Lumateperone DRUG

Lumateperone 42 mg capsules administered orally, once daily

Lumateperone 42 mg

Placebo DRUG

Matching capsules administered orally, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent before the initiation of any study specific procedures;
• Male or female inpatient, between the ages of 18 and 75 years, inclusive;
• Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
• YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
• Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.

You may not qualify if:

• Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:
• Schizophrenia, schizoaffective disorder, or other psychotic disorders;
• Dementia or other cognitive disorders;
• Intellectual disability;
• Moderate or severe substance use disorder (excluding for nicotine);
• Experiencing first manic episode;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
• At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
• At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
• At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
• At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
• Considered to be an imminent danger to himself/herself or others.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (42)

Clinical Site

Rogers, Arkansas, 72758, United States

RECRUITING

Clinical Site

Bellflower, California, 90706, United States

NOT YET RECRUITING

Clinical Site

Culver City, California, 90230, United States

RECRUITING

Clinical Site

Garden Grove, California, 92845, United States

RECRUITING

Clinical Site

Lemon Grove, California, 91945, United States

RECRUITING

Clinical Site

Montclair, California, 91763, United States

RECRUITING

Clinical Site

Hallandale, Florida, 33009, United States

RECRUITING

Clinical Site

Hialeah, Florida, 33016, United States

RECRUITING

Clinical Site

Miami, Florida, 33184, United States

NOT YET RECRUITING

Clinical Site

Miami Gardens, Florida, 33056, United States

NOT YET RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

Miami Springs, Florida, 33166, United States

RECRUITING

Clinical Site

Orlando, Florida, 32807, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30324, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30338, United States

NOT YET RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Savannah, Georgia, 31405, United States

RECRUITING

Clinical Site

Shreveport, Louisiana, 71101, United States

RECRUITING

Clinical Site

Marlton, New Jersey, 08053, United States

RECRUITING

Clinical Site

North Canton, Ohio, 44720, United States

RECRUITING

Clinical Site

Austin, Texas, 78701, United States

NOT YET RECRUITING

Clinical Site

Austin, Texas, 78754, United States

RECRUITING

Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Clinical Site

Lovech, 5500, Bulgaria

RECRUITING

Clinical Site

Rousse, Bulgaria

RECRUITING

Clinical Site

Sofia, 1377, Bulgaria

RECRUITING

Clinical Site

Stara Zagora, 6000, Bulgaria

RECRUITING

Clinical Site

Veliko Tarnovo, 5000, Bulgaria

RECRUITING

Clinical Site

Vratsa, 3000, Bulgaria

RECRUITING

Clinical Site

Split, 21000, Croatia

RECRUITING

Clinical Site

Zagreb, 10000, Croatia

RECRUITING

Clinical Site

Zagreb, 10090, Croatia

RECRUITING

Clinical Site

Guwahati, Assam, 781032, India

RECRUITING

Clinical Site

Mangalore, Karnataka, 575018, India

RECRUITING

Clinical Site

Mysore, Karnataka, 570001, India

RECRUITING

Clinical Site

Nashik, Maharashtra, 422005, India

RECRUITING

Clinical Site

Ludhiana, Punjab, 141001, India

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Kovin, 26220, Serbia

RECRUITING

Clinical Site

Kragujevac, 34000, Serbia

RECRUITING

Clinical Site

Novi Kneževac, 23330, Serbia

RECRUITING

Clinical Site

Novi Sad, 21000, Serbia

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

(646) 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 19, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (3); BU (6); US (23); IN (5); SE (5)