Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Recruiting · NCT06229210 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
5 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 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 criteria
- 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.
Where it is running
60 locations listed across 19 US states.
- Southwest Autism Research and Resource Center - Phoenix, Arizona, United States
- Pillar Clinical Research, LLC - Little Rock, Arkansas, United States
- Advanced Research Center, Inc - Anaheim, California, United States
- National Institute Of Clinical Research - Garden Grove, California, United States
- Excell Research Inc - Oceanside, California, United States
- Inland Psychiatric Medical Group Inc - Redlands, California, United States
- University Of California - Davis - Sacramento, California, United States
- University Of California San Diego - 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
- Sarkis Clinical Trials - Gainesville, Florida, United States
- United Research Institute - Hialeah, Florida, United States
- Advanced Research Institute of Miami - Homestead, Florida, United States
- Green Leaf Clinical Trials - Jacksonville, 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
- Blue Medical Research - 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
- Diverse Clinical Research LLC - Miami, Florida, United States
- Links Clinical Trials - 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
- Clinical Research Center of Florida - Pompano Beach, Florida, United States
- University of South Florida Rothman Center of Neuropsychiatry - St. Petersburg, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- CenExeli Research LLC - Atlanta, Georgia, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- Atlanta Behavioral Research, LLC - Atlanta, Georgia, United States
- Salveo Integrative Health Inc - Lawrenceville, Georgia, United States
- CenExeli Research LLC 1 - Savannah, Georgia, United States
- Baber Research Group - Naperville, Illinois, United States
- Riley Hospital for Children at Indiana University Health - Indianapolis, Indiana, United States
- Neurobehavioral Medicine Group - Bloomfield Hills, Michigan, United States
- Midwest Research Group 1 - Saint Charles, Missouri, United States
- Alivation Research LLC - Lincoln, Nebraska, United States
- Clinical Research of Southern Nevada, LLC - Las Vegas, Nevada, United States
- NYU Child Study Center - New York, New York, United States
- Richmond Behavioral Associates - Staten Island, New York, United States
- Quest Therapeutics of Avon Lake - 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
- Cutting Edge Research Group - Oklahoma City, Oklahoma, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- Access Clinical Trials - Nashville, Tennessee, United States
- Texas Research Group - Coppell, Texas, United States
- PsyMed Solutions - Fort Worth, Texas, United States
- Kaleidoscope Clinical Research - Houston, Texas, United States
- Red Oak Psychiatry Associates - Houston, Texas, United States
- AIM Trials - Plano, 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
- Clinic of Neurology and Psychiatry for Children and Youth - Belgrade, Serbia
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →