RECRUITING

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

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Conditions

Bipolar Disorder, Manic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-07-17
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06462612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide written informed consent before the initiation of any study specific procedures;
  2. 2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
  3. 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. 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. 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.
  1. 1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:
  2. 1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
  3. 2. Dementia or other cognitive disorders;
  4. 3. Intellectual disability;
  5. 4. Moderate or severe substance use disorder (excluding for nicotine);
  6. 2. Experiencing first manic episode;
  7. 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
  8. 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
  9. 2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
  10. 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
  11. 4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
  12. 5. Considered to be an imminent danger to himself/herself or others.

Contacts and Locations

Study Contact

ITI Clinical Trials
CONTACT
(646) 440-9333
ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site
Bentonville, Arkansas, 72712
United States
Clinical Site
Little Rock, Arkansas, 72211
United States
Clinical Site
Anaheim, California, 92805
United States
Clinical Site
Cerritos, California, 90703
United States
Clinical Site
Orange, California, 92868
United States
Clinical Site
Torrance, California, 90504
United States
Clinical Site
Hialeah, Florida, 33012
United States
Clinical Site
Miami Lakes, Florida, 33014
United States
Clinical Site
Miami Lakes, Florida, 33016
United States
Clinical Site
Miami, Florida, 33122
United States
Clinical Site
Miami, Florida, 33135
United States
Clinical Site
Miami, Florida, 33145
United States
Clinical Site
Tampa, Florida, 33629
United States
Clinical Site
West Palm Beach, Florida, 33407
United States
Clinical Site
Atlanta, Georgia, 30331
United States
Clinical Site
Stockbridge, Georgia, 30281
United States
Clinical Site
Chicago, Illinois, 60641
United States
Clinical Site
Glen Oaks, New York, 11004
United States
Clinical Site
Cincinnati, Ohio, 45219
United States
Clinical Site
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder, Manic