Tests lumateperone safety in children with schizophrenia, bipolar or autism
Tests lumateperone's safety in children with schizophrenia, bipolar disorder or autism.
Plain-language title generated from the registry record
Registry title: Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Key facts
- Where
- Anaheim, Atlanta, Avon Lake, Bellevue, Bloomfield Hills, Cincinnati, Colorado Springs, Coppell, Everett, Fort Myers, Fort Worth, Gainesville, Garden Grove, Garfield Heights, Hialeah, Homestead, Houston, Indianapolis, Jacksonville, Las Vegas, Lawrenceville, Lincoln, Little Rock, Miami, Miami Gardens, Miami Lakes, Naperville, Nashville, New York, Norman, Oceanside, Oklahoma City, Orlando, Phoenix, Plano, Pompano Beach, Redlands, Richmond, Sacramento, Saint Charles, San Diego, Savannah, St. Petersburg, Staten Island, West Covina, and West Palm Beach, United StatesSee the 59 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 5 and 17 years old?
Source: NCT06229210, who can take part
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
- CenExeli Research LLCAtlanta, United StatesTaking people
- Atlanta Behavioral Research, LLCAtlanta, United StatesNo longer taking part
- Quest Therapeutics of Avon LakeAvon Lake, United StatesNo longer taking part
- Northwest Clinical Research CenterBellevue, United StatesTaking people
- NeuroBehavioral Medicine GroupBloomfield Hills, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- MCB Clinical Research Centers LLCColorado Springs, United StatesNo longer taking part
- Texas Research GroupCoppell, United StatesTaking people
- Core Clinical ResearchEverett, United StatesTaking people
- Royal Palm Clinical ResearchFort Myers, United StatesNo longer taking part
- PsyMed SolutionsFort Worth, United StatesTaking people
- Sarkis Clinical TrialsGainesville, United StatesTaking people
- National Institute Of Clinical ResearchGarden Grove, United StatesTaking people
- Charak Center for Health and WellnessGarfield Heights, United StatesTaking people
- United Research InstituteHialeah, United StatesTaking people
- Advanced Research Institute of MiamiHomestead, United StatesTaking people
- Kaleidoscope Clinical ResearchHouston, United StatesTaking people
- Red Oak Psychiatry AssociatesHouston, United StatesTaking people
- Riley Hospital for Children at Indiana University HealthIndianapolis, United StatesNo longer taking part
- Green Leaf Clinical TrialsJacksonville, United StatesTaking people
- Clinical Research of Southern Nevada, LLCLas Vegas, United StatesTaking people
- Salveo Integrative Health IncLawrenceville, United StatesNo longer taking part
- Alivation Research, LLCLincoln, United StatesTaking people
- Pillar Clinical Research, LLCLittle Rock, United StatesTaking people
- Blue Medical ResearchMiami, United StatesTaking people
- Care Research Center IncMiami, United StatesTaking people
- Columbus Clinical Services LLCMiami, United StatesTaking people
- Diverse Clinical Research LLCMiami, United StatesTaking people
- Envision Trials LLCMiami, United StatesTaking people
- Links Clinical TrialsMiami, United StatesTaking people
- AP Medical ResearchMiami, United StatesNo longer taking part
- GTL Medical and Research GroupMiami, 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
- Baber Research GroupNaperville, United StatesTaking people
- Access Clinical TrialsNashville, United StatesTaking people
- NYU Child Study CenterNew York, United StatesTaking people
- Sooner Clinical ResearchNorman, United StatesTaking people
- Excell Research, Inc.Oceanside, United StatesTaking people
- Cutting Edge Research GroupOklahoma City, United StatesNo longer taking part
- APG Research, LLCOrlando, United StatesNo longer taking part
- Southwest Autism Research and Resource CenterPhoenix, United StatesTaking people
- AIM TrialsPlano, United StatesTaking people
- Clinical Research Center of FloridaPompano Beach, United StatesTaking people
- Inland Psychiatric Medical Group, Inc.Redlands, United StatesTaking people
- Perceptive Pharma ResearchRichmond, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- University of California - DavisSacramento, United StatesTaking people
- Midwest Research Group 1Saint Charles, United StatesTaking people
- University of California San DiegoSan Diego, United StatesNo longer taking part
- CenExeli Research LLC 1Savannah, United StatesTaking people
- University of South Florida Rothman Center of NeuropsychiatrySt. Petersburg, United StatesTaking people
- Richmond Behavioral AssociatesStaten Island, United StatesTaking people
- Next Level Clinical Trials, LLCWest Covina, United StatesTaking people
- Health Synergy Clinical ResearchWest Palm Beach, United StatesTaking people
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
- NCT06229210EU 2023-507068-38-00
- Record updated
- 3 November 2026
- Original description
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.Read full original descriptionShow less
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Inclusion: Able to provide consent as follows:; The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; The patient must provide written assent to study enrollment; Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study; Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.
Exclusion: Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:; ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records; For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary; In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their 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) of the CDRS-R (for bipolar disorder patients only); or; The patient is considered to be an imminent danger to him/herself or others.