RECRUITING

Study of Lumateperone in the Acute 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:2024-06-19
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06462586

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
Rogers, Arkansas, 72758
United States
Clinical Site
Bellflower, California, 90706
United States
Clinical Site
Culver City, California, 90230
United States
Clinical Site
Garden Grove, California, 92845
United States
Clinical Site
Lemon Grove, California, 91945
United States
Clinical Site
Montclair, California, 91763
United States
Clinical Site
Hallandale Beach, Florida, 33009
United States
Clinical Site
Hialeah, Florida, 33016
United States
Clinical Site
Miami Gardens, Florida, 33056
United States
Clinical Site
Miami Lakes, Florida, 33016
United States
Clinical Site
Miami Springs, Florida, 33166
United States
Clinical Site
Miami, Florida, 33184
United States
Clinical Site
Orlando, Florida, 32807
United States
Clinical Site
Atlanta, Georgia, 30324
United States
Clinical Site
Atlanta, Georgia, 30338
United States
Clinical Site
Decatur, Georgia, 30030
United States
Clinical Site
Savannah, Georgia, 31405
United States
Clinical Site
Shreveport, Louisiana, 71101
United States
Clinical Site
Marlton, New Jersey, 08053
United States
Clinical Site
North Canton, Ohio, 44720
United States
Clinical Site
Austin, Texas, 78701
United States
Clinical Site
Austin, Texas, 78754
United States
Clinical Site
DeSoto, Texas, 75115
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 Date2024-06-19
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-06-19
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder, Manic