Tests lumateperone for depression in teens with bipolar disorder
Compares lumateperone with placebo in children aged 10 to 17 with bipolar depression.
Plain-language title generated from the registry record
Registry title: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Key facts
- Where
- Anaheim, Atlanta, Austin, Avon Lake, Baltimore, Beaumont, Bellevue, Bloomfield Hills, Chicago, Cincinnati, Colorado Springs, Dothan, Elgin, Everett, Flower Mound, Fort Myers, Garfield Heights, Hialeah, Homestead, Houston, Indianapolis, Lawrenceville, Lincoln, Little Rock, Miami, Miami Gardens, Miami Lakes, New York, Oklahoma City, Orlando, Redlands, Richmond, Sacramento, Saint Charles, San Diego, Savannah, St Louis, West Covina, West Palm Beach, and Westlake, United StatesSee the 56 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT06372964, who can take part
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- CenExeli Research LLCAtlanta, United StatesTaking people
- Advanced Discovery ResearchAtlanta, United StatesNo longer taking part
- The University of Texas at AustinAustin, United StatesTaking people
- BioBehavioral Research of Austin PCAustin, United StatesNo longer taking part
- Haidar Almhana NiedingAvon Lake, United StatesNo longer taking part
- MTP Psychiatry, LLCBaltimore, United StatesNo longer taking part
- REX Clinical Trials LLCBeaumont, United StatesTaking people
- Northwest Clinical Research CenterBellevue, United StatesTaking people
- NeuroBehavioral Medicine GroupBloomfield Hills, United StatesTaking people
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- MCB Clinical Research Centers LLCColorado Springs, United StatesNo longer taking part
- Harmonex Neuroscience ResearchDothan, United StatesTaking people
- Revive Research InstituteElgin, United StatesTaking people
- Core Clinical ResearchEverett, United StatesTaking people
- North Pointe PsychiatryFlower Mound, United StatesNo longer taking part
- Royal Palm Clinical ResearchFort Myers, United StatesNo longer taking part
- Charak Center for Health and WellnessGarfield Heights, United StatesTaking people
- United Research InstituteHialeah, United StatesNo longer taking part
- Advanced Research Institute of MiamiHomestead, United StatesNo longer taking part
- Kaleidoscope Clinical ResearchHouston, United StatesTaking people
- Red Oak Psychiatry AssociatesHouston, United StatesNo longer taking part
- Indiana UniversityIndianapolis, United StatesNo longer taking part
- Salveo Integrative Health IncLawrenceville, United StatesNo longer taking part
- Alivation Research, LLCLincoln, United StatesTaking people
- Pillar Clinical Research, LLCLittle Rock, United StatesTaking people
- Care Research Center IncMiami, United StatesTaking people
- Envision Trials LLCMiami, United StatesTaking people
- HealthMed Clinical Center IncMiami, United StatesTaking people
- Links Clinical TrialsMiami, United StatesTaking people
- AP Medical ResearchMiami, United StatesNo longer taking part
- Columbus Clinical Services LLCMiami, United StatesNo longer taking part
- GTL Medical and Research GroupMiami, United StatesNo longer taking part
- Ocean Blue Medical Research Center Inc.Miami, United StatesNo longer taking part
- SouthGen Clinical Research LLCMiami, United StatesNo longer taking part
- Vital Care ResearchMiami, United StatesNo longer taking part
- New Med Research IncMiami Gardens, United StatesTaking people
- The Angel Medical Research CorporationMiami Gardens, United StatesTaking people
- Riveldi Biomedical ResearchMiami Lakes, United StatesTaking people
- NYU Child Study CenterNew York, United StatesTaking people
- Sooner Clinical ResearchOklahoma City, United StatesTaking people
- SP Research, PLLC (dba Rivus Wellness & Research Institute)Oklahoma City, United StatesTaking people
- Cutting Edge Research GroupOklahoma City, United StatesNo longer taking part
- APG Research, LLCOrlando, United StatesTaking people
- Inland Psychiatric Medical Group, Inc.Redlands, United StatesTaking people
- Perceptive Pharma ResearchRichmond, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- UC Davis Health SystemSacramento, United StatesTaking people
- Midwest Research GroupSaint Charles, United StatesTaking people
- University of California San Diego Medical CenterSan Diego, United StatesNo longer taking part
- CenExeli Research LLC 1Savannah, United StatesTaking people
- Washington University School of Medicine Child and Adolescent Psychiatry ClinicSt Louis, United StatesNo longer taking part
- Next Level Clinical Trials, LLCWest Covina, United StatesTaking people
- Health Synergy Clinical ResearchWest Palm Beach, United StatesTaking people
- Westlake America ClinicWestlake, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Intra-Cellular Therapies, Inc.
- Trial code
- NCT06372964
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
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).
Inclusion: 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: 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; Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization; 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; Intellectual disability based on Investigator opinion and DSM-5 criteria; 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.