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

Bipolar Disorder, Manic Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462586
• Other study ID #: ITI-007-451
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: (646) 440-9333
• Email: ITCIClinicalTrials[@]itci-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able to provide written informed consent before the initiation of any study specific procedures;

2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;

3. 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);

4. 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;

5. 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.

Exclusion Criteria:

1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:

1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;

2. Dementia or other cognitive disorders;

3. Intellectual disability;

4. Moderate or severe substance use disorder (excluding for nicotine);

2. Experiencing first manic episode;

3. 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

1. 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

2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or

3. 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

4. At Screening or Baseline, scores = 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or

5. Considered to be an imminent danger to himself/herself or others.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder, Manic

Intervention

Drug:
• Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
• Placebo
Matching capsules administered orally, once daily

Locations

Country	Name	City	State
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Bellflower	California
United States	Clinical Site	Culver City	California
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	DeSoto	Texas
United States	Clinical Site	Garden Grove	California
United States	Clinical Site	Hallandale Beach	Florida
United States	Clinical Site	Hialeah	Florida
United States	Clinical Site	Lemon Grove	California
United States	Clinical Site	Marlton	New Jersey
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Miami Gardens	Florida
United States	Clinical Site	Miami Lakes	Florida
United States	Clinical Site	Miami Springs	Florida
United States	Clinical Site	Montclair	California
United States	Clinical Site	North Canton	Ohio
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	Savannah	Georgia
United States	Clinical Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impression Scale-Severity (CGI-S)	The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).	Week 3