Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 26-week study tests how safe lumateperone is and how well children and teens can tolerate it. It is for young people with schizophrenia, bipolar disorder, or autism. Everyone in the study knows which medicine they receive.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A parent or legal guardian must give written permission, and the child or teen must agree in writing.
- Must be ages 13–17 with schizophrenia, ages 10–17 with bipolar I or II disorder, or ages 5–17 with autism.
- The main diagnosis must be confirmed using the study's mental health rules and interview.
- Must receive care without staying in a hospital and be expected to continue this way during the study.
- If joining from the earlier study, the study doctor must decide that the patient safely finished it.
Who can't join
- A main mental health diagnosis other than schizophrenia, bipolar I or II disorder, or autism.
- Schizophrenia with catatonia, which can affect movement and response to others.
- Bipolar disorder with psychotic features, such as seeing or hearing things that are not there.
- ADHD is allowed, but any stimulant medicines for it must be unchanged for 30 days before screening and should stay unchanged during the study.
- For patients with autism, severe or very severe limits in learning and daily living skills are not allowed. Mild or moderate limits may be allowed by the study doctor.
- The study doctor finds a serious risk of suicidal behavior, or an immediate danger to the patient or others.
- Certain suicidal thoughts on study checks within 6 months before screening or between screening and the starting visit, or any suicide attempt within 2 years before screening.
- For patients with bipolar disorder, a score above 3 on the depression test's suicidal-thoughts question at screening or the starting visit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (59)
AR
- Pillar Clinical Research, LLC · Little Rock, AR 72204More trials in Little Rock
AZ
- Southwest Autism Research and Resource Center · Phoenix, AZ 85006More trials in Phoenix
CA
- Advanced Research Center, Inc · Anaheim, CA 92805More trials in Anaheim
- National Institute Of Clinical Research · Garden Grove, CA 92844More trials in Garden Grove
- Excell Research Inc · Oceanside, CA 92056More trials in Oceanside
- Inland Psychiatric Medical Group Inc · Redlands, CA 92373More trials in Redlands
- University Of California - Davis · Sacramento, CA 95817More trials in Sacramento
- University Of California San Diego · San Diego, CA 92103More trials in San Diego
- Next Level Clinical Trials, LLC · West Covina, CA 91790More trials in West Covina
CO
- MCB Clinical Research Centers LLC · Colorado Springs, CO 80910More trials in Colorado Springs
FL
- Royal Palm Clinical Research · Fort Myers, FL 33901More trials in Fort Myers
- Sarkis Clinical Trials · Gainesville, FL 32607More trials in Gainesville
- United Research Institute · Hialeah, FL 33012More trials in Hialeah
- Advanced Research Institute of Miami · Homestead, FL 33033More trials in Homestead
- Green Leaf Clinical Trials · Jacksonville, FL 32258More trials in Jacksonville
- Vital Care Research · Miami, FL 33122More trials in Miami
- Columbus Clinical Services LLC · Miami, FL 33125More trials in Miami
- Care Research Center Inc · Miami, FL 33130More trials in Miami
- Blue Medical Research · Miami, FL 33144More trials in Miami
- AP Medical Research · Miami, FL 33165More trials in Miami
- Envision Trials LLC · Miami, FL 33166More trials in Miami
- GTL Medical and Research Group · Miami, FL 33173More trials in Miami
- Diverse Clinical Research LLC · Miami, FL 33175More trials in Miami
- Links Clinical Trials · Miami, FL 33176More trials in Miami
- New Med Research Inc · Miami Gardens, FL 33056More trials in Miami Gardens
- The Angel Medical Research Corporation · Miami Gardens, FL 33169More trials in Miami Gardens
- Riveldi Biomedical Research · Miami Lakes, FL 33014More trials in Miami Lakes
- APG Research LLC · Orlando, FL 32803More trials in Orlando
- Clinical Research Center of Florida · Pompano Beach, FL 33060More trials in Pompano Beach
- University of South Florida Rothman Center of Neuropsychiatry · St. Petersburg, FL 33701More trials in St. Petersburg
- Health Synergy Clinical Research · West Palm Beach, FL 33407More trials in West Palm Beach
GA
- CenExeli Research LLC · Atlanta, GA 30030More trials in Atlanta
- Atlanta Center for Medical Research · Atlanta, GA 30331More trials in Atlanta
- Atlanta Behavioral Research, LLC · Atlanta, GA 30338More trials in Atlanta
- Salveo Integrative Health Inc · Lawrenceville, GA 30046More trials in Lawrenceville
- CenExeli Research LLC 1 · Savannah, GA 31405More trials in Savannah
IL
- Baber Research Group · Naperville, IL 60563More trials in Naperville
IN
- Riley Hospital for Children at Indiana University Health · Indianapolis, IN 46202More trials in Indianapolis
MI
- Neurobehavioral Medicine Group · Bloomfield Hills, MI 48302More trials in Bloomfield Hills
MO
- Midwest Research Group 1 · Saint Charles, MO 63304More trials in Saint Charles
NE
- Alivation Research LLC · Lincoln, NE 68526More trials in Lincoln
NV
- Clinical Research of Southern Nevada, LLC · Las Vegas, NV 89128More trials in Las Vegas
NY
- NYU Child Study Center · New York, NY 10016More trials in New York
- Richmond Behavioral Associates · Staten Island, NY 10314More trials in Staten Island
OH
- Quest Therapeutics of Avon Lake · Avon Lake, OH 44012More trials in Avon Lake
- University of Cincinnati Medical Center · Cincinnati, OH 45219More trials in Cincinnati
- Charak Center for Health and Wellness · Garfield Heights, OH 44125More trials in Garfield Heights
OK
- Cutting Edge Research Group · Oklahoma City, OK 73116More trials in Oklahoma City
- Sooner Clinical Research · Oklahoma City, OK 73116More trials in Oklahoma City
TN
- Access Clinical Trials · Nashville, TN 37203More trials in Nashville
TX
- Texas Research Group · Coppell, TX 75019More trials in Coppell
- PsyMed Solutions · Fort Worth, TX 76132More trials in Fort Worth
- Kaleidoscope Clinical Research · Houston, TX 77089More trials in Houston
- Red Oak Psychiatry Associates · Houston, TX 77090More trials in Houston
- AIM Trials · Plano, TX 75093More trials in Plano
- Perceptive Pharma Research · Richmond, TX 77407More trials in Richmond
VA
- Virginia Commonwealth University · Richmond, VA 23220More trials in Richmond
WA
- Northwest Clinical Research Center · Bellevue, WA 98007More trials in Bellevue
- Core Clinical Research · Everett, WA 98201More trials in Everett