Lumateperone: Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication
Study summary
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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Common Adverse Events — Up to 6 months An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Trial sites (64)
Facility
City
Region
Status
Southwest Autism Research and Resource Center
Phoenix
Arizona
Recruiting
Pillar Clinical Research, LLC
Little Rock
Arkansas
Recruiting
Advanced Research Center, Inc
Anaheim
California
Recruiting
National Institute Of Clinical Research
Garden Grove
California
Recruiting
Excell Research Inc
Oceanside
California
Recruiting
Inland Psychiatric Medical Group Inc
Redlands
California
Recruiting
University Of California - Davis
Sacramento
California
Recruiting
University Of California San Diego
San Diego
California
Completed
Next Level Clinical Trials, LLC
West Covina
California
Recruiting
MCB Clinical Research Centers LLC
Colorado Springs
Colorado
Completed
Royal Palm Clinical Research
Fort Myers
Florida
Suspended
Sarkis Clinical Trials
Gainesville
Florida
Recruiting
United Research Institute
Hialeah
Florida
Recruiting
Advanced Research Institute of Miami
Homestead
Florida
Recruiting
Green Leaf Clinical Trials
Jacksonville
Florida
Recruiting
Vital Care Research
Miami
Florida
Suspended
Columbus Clinical Services LLC
Miami
Florida
Recruiting
Care Research Center Inc
Miami
Florida
Recruiting
Blue Medical Research
Miami
Florida
Recruiting
AP Medical Research
Miami
Florida
Suspended
Envision Trials LLC
Miami
Florida
Recruiting
GTL Medical and Research Group
Miami
Florida
Completed
Diverse Clinical Research LLC
Miami
Florida
Recruiting
Links Clinical Trials
Miami
Florida
Recruiting
New Med Research Inc
Miami Gardens
Florida
Recruiting
The Angel Medical Research Corporation
Miami Gardens
Florida
Recruiting
Riveldi Biomedical Research
Miami Lakes
Florida
Recruiting
APG Research LLC
Orlando
Florida
Suspended
Clinical Research Center of Florida
Pompano Beach
Florida
Recruiting
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg
Florida
Recruiting
Health Synergy Clinical Research
West Palm Beach
Florida
Recruiting
CenExeli Research LLC
Atlanta
Georgia
Recruiting
Atlanta Center for Medical Research
Atlanta
Georgia
Recruiting
Atlanta Behavioral Research, LLC
Atlanta
Georgia
Completed
Salveo Integrative Health Inc
Lawrenceville
Georgia
Completed
CenExeli Research LLC 1
Savannah
Georgia
Recruiting
Baber Research Group
Naperville
Illinois
Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis
Indiana
Completed
Neurobehavioral Medicine Group
Bloomfield Hills
Michigan
Recruiting
Midwest Research Group 1
Saint Charles
Missouri
Recruiting
+ 24 more sites — see the full list on the official registry below.
More Intra-Cellular Therapies, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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