Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Recruiting · NCT06372964 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
LumateperonePlacebo
What this trial is about
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Who can take part
Age range
10 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Able to provide consent as follows:
- The Legally Authorized Representative (LAR) must provide written, informed consent.
- The patient must provide written assent;
- Male or female patients 10 to 17 years of age, inclusive;
- Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
- Subject has a lifetime history of at least one manic or hypomanic episode.
- Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
- CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
- Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.
Exclusion criteria
- Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
- Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
- Intellectual disability based on Investigator opinion and DSM-5 criteria
- Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
- Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
- The patient is considered to be an imminent danger to him/herself or others.
Where it is running
60 locations listed across 18 US states.
- Harmonex Neuroscience Research - Dothan, Alabama, United States
- Pillar Clinical Research, LLC - Little Rock, Arkansas, United States
- Advanced Research Center, Inc - Anaheim, California, United States
- Inland Psychiatric Medical Group Inc - Redlands, California, United States
- UC Davis Health System - Sacramento, California, United States
- University of California San Diego Medical Center - San Diego, California, United States
- Next Level Clinical Trials, LLC - West Covina, California, United States
- MCB Clinical Research Centers LLC - Colorado Springs, Colorado, United States
- Royal Palm Clinical Research - Fort Myers, Florida, United States
- United Research Institute - Hialeah, Florida, United States
- Advanced Research Institute of Miami - Homestead, Florida, United States
- Vital Care Research - Miami, Florida, United States
- Columbus Clinical Services LLC - Miami, Florida, United States
- Care Research Center Inc - Miami, Florida, United States
- HealthMed Clinical Center Inc - Miami, Florida, United States
- Ocean Blue Medical Research Center Inc. - Miami, Florida, United States
- AP Medical Research - Miami, Florida, United States
- Envision Trials LLC - Miami, Florida, United States
- GTL Medical and Research Group - Miami, Florida, United States
- Links Clinical Trials - Miami, Florida, United States
- SouthGen Clinical Research LLC - Miami, Florida, United States
- New Med Research Inc - Miami Gardens, Florida, United States
- The Angel Medical Research Corporation - Miami Gardens, Florida, United States
- Riveldi Biomedical Research - Miami Lakes, Florida, United States
- APG Research LLC - Orlando, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- CenExeli Research LLC - Atlanta, Georgia, United States
- Advanced Discovery Research - Atlanta, Georgia, United States
- Salveo Integrative Health Inc - Lawrenceville, Georgia, United States
- CenExeli Research LLC 1 - Savannah, Georgia, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago, Illinois, United States
- Revive Research Institute - Elgin, Illinois, United States
- Indiana University - Indianapolis, Indiana, United States
- MTP Psychiatry LLC - Baltimore, Maryland, United States
- Neurobehavioral Medicine Group - Bloomfield Hills, Michigan, United States
- Midwest Research Group - Saint Charles, Missouri, United States
- Washington University School of Medicine Child and Adolescent Psychiatry Clinic - St Louis, Missouri, United States
- Alivation Research LLC - Lincoln, Nebraska, United States
- NYU Child Study Center - New York, New York, United States
- Haidar Almhana Nieding - Avon Lake, Ohio, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Charak Center for Health and Wellness - Garfield Heights, Ohio, United States
- Westlake America Clinic - Westlake, Ohio, United States
- SP Research, PLLC (dba Rivus Wellness & Research Institute) - Oklahoma City, Oklahoma, United States
- Cutting Edge Research Group - Oklahoma City, Oklahoma, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- The University of Texas at Austin - Austin, Texas, United States
- BioBehavioral Research of Austin PC - Austin, Texas, United States
- REX Clinical Trials LLC - Beaumont, Texas, United States
- North Pointe Psychiatry - Flower Mound, Texas, United States
- Kaleidoscope Clinical Research - Houston, Texas, United States
- Red Oak Psychiatry Associates - Houston, Texas, United States
- Perceptive Pharma Research - Richmond, Texas, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Core Clinical Research - Everett, Washington, United States
- Ratandeep Surgical Hospital And Endoscopy Clinic - Ahmedabad, India
- Society for Psychiatric Update and Research Shanti Nursing Home - Aurangabad, India
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA - Barranquilla, Colombia
- Clinic of Neurology and Psychiatry for Children and Youth - Belgrade, Serbia
Showing 60 of 68 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →