Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Start Date
1/25/2024
Completion Date
4/28/2032
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.
Detailed Description
The study will enroll pediatric patients as follows: De Novo Patients: * Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020) * Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030) * Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035) Rollover Patients: * Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study. * Patients with irritability associated with autism spectrum disorder who are enrolling directly from a lead-in efficacy study. This study will be conducted as follows: * A Screening Period of up to 2 weeks during which patient eligibility will be assessed. * A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily. * A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone.
Eligibility Criteria
Age Range: 5 years to 17 years
Interventions
Lumateperone
Conditions
Locations
Southwest Autism Research and Resource Center
Phoenix, Arizona 85006
United States
Pillar Clinical Research, LLC
Little Rock, Arkansas 72204
United States
Advanced Research Center, Inc
Anaheim, California 92805
United States
National Institute Of Clinical Research
Garden Grove, California 92844
United States
Excell Research Inc
Oceanside, California 92056
United States
Inland Psychiatric Medical Group Inc
Redlands, California 92373
United States
University Of California - Davis
Sacramento, California 95817
United States
University Of California San Diego
San Diego, California 92103
United States
Next Level Clinical Trials, LLC
West Covina, California 91790
United States
MCB Clinical Research Centers LLC
Colorado Springs, Colorado 80910
United States
Royal Palm Clinical Research
Fort Myers, Florida 33901
United States
Sarkis Clinical Trials
Gainesville, Florida 32607
United States
United Research Institute
Hialeah, Florida 33012
United States
Advanced Research Institute of Miami
Homestead, Florida 33033
United States
Vital Care Research
Miami, Florida 33122
United States
Columbus Clinical Services LLC
Miami, Florida 33125
United States
Care Research Center Inc
Miami, Florida 33130
United States
Blue Medical Research
Miami, Florida 33144
United States
AP Medical Research
Miami, Florida 33165
United States
Envision Trials LLC
Miami, Florida 33166
United States
GTL Medical and Research Group
Miami, Florida 33173
United States
Diverse Clinical Research LLC
Miami, Florida 33175
United States
Links Clinical Trials
Miami, Florida 33176
United States
New Med Research Inc
Miami Gardens, Florida 33056
United States
The Angel Medical Research Corporation
Miami Gardens, Florida 33169
United States
Riveldi Biomedical Research
Miami Lakes, Florida 33014
United States
APG Research LLC
Orlando, Florida 32803
United States
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United States
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida 33701
United States
Health Synergy Clinical Research
West Palm Beach, Florida 33407
United States
CenExeli Research LLC
Atlanta, Georgia 30030
United States
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia 30338
United States
Salveo Integrative Health Inc
Lawrenceville, Georgia 30046
United States
CenExeli Research LLC 1
Savannah, Georgia 31405
United States
Baber Research Group
Naperville, Illinois 60563
United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
United States
Midwest Research Group 1
Saint Charles, Missouri 63304
United States
Alivation Research LLC
Lincoln, Nebraska 68526
United States
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada 89128
United States
Richmond Behavioral Associates
Staten Island, New York 10314
United States
Quest Therapeutics of Avon Lake
Avon Lake, Ohio 44012
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Charak Center for Health and Wellness
Garfield Heights, Ohio 44125
United States
Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
United States
Sooner Clinical Research
Oklahoma City, Oklahoma 73116
United States
Access Clinical Trials
Nashville, Tennessee 37203
United States
Texas Research Group
Coppell, Texas 75019
United States
PsyMed Solutions
Fort Worth, Texas 76132
United States
Kaleidoscope Clinical Research
Houston, Texas 77089
United States
Red Oak Psychiatry Associates
Houston, Texas 77090
United States
AIM Trials
Plano, Texas 75093
United States
Perceptive Pharma Research
Richmond, Texas 77407
United States
Virginia Commonwealth University
Richmond, Virginia 23220
United States
Northwest Clinical Research Center
Bellevue, Washington 98007
United States
Core Clinical Research
Everett, Washington 98201
United States
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade, 11000
Serbia
Institute of Mental Health Serbia
Belgrade, 11000
Serbia
University Clinical Center NIS
Niš, 18000
Serbia
Clinical Center of Vojvodina
Novi Sad, 21000
Serbia