Long-term Antipsychotic Pediatric Safety Trial

CompletedOBSERVATIONAL
Enrollment

509

Participants

Timeline

Start Date

January 10, 2019

Primary Completion Date

November 21, 2023

Study Completion Date

November 21, 2023

Conditions
Weight, Body
Interventions
DRUG

Risperidone

Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder

DRUG

Aripiprazole

Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder

Trial Locations (37)

10461

Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx

21205

Kennedy Krieger Institute, Baltimore

22903

University of Virginia, Charlottesville

27278

Behavioral Health Hospital Oupatient Clinic, Greensboro

27403

Cone Health Outpatient Behavioral Health, Greensboro

27599

University of North Carolina at Chapel Hill, Chapel Hill

27609

Carolina Partners in Mental HealthCare, PLLC, Raleigh

27705

Duke Child and Family Study Center, Durham

30017

IACT Health, Grayson

30082

Attalla Consultants LLC dba Institute for Behavioral Medicine, Smyrna

31903

Valley Healthcare System, Columbus

33126

Clinical Trials Solution, Miami

South Florida Behavioral Health Network, Miami

33161

Scientific Clinical Research, Inc., North Miami

36303

Harmonex Neuroscience Research, Dothan

38103

Le Bonheur Children's Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

46601

Beacon Medical Group, South Bend

48302

Neurobehavioral Medicine Group, Bloomfield

49548

Pine Rest Christian Mental Health Services, Grand Rapids

57108

Avera McKennan University Psychiatry Associates, Sioux Falls

60563

AMR-Baber Research, Inc., Naperville

63110

Washington University, St Louis

68131

University of Nebraska Medical Center, Omaha

72202

Arkansas Children's Research Institute, Little Rock

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

78759

BioBehavioral Research of Austin, Austin

85006

Southwest Autism Research & Resource Center, Phoenix

90024

UCLA Semel Institute, Los Angeles

93594

OM Research, Lancaster

06520

Yale Child Study Center, New Haven

02114

Massachusetts General Hospital, Boston

02421

Massachusetts General Hospital, Lurie Center for Autism, Lexington

01655

University of Massachusetts Medical School, Worcester

45219-2492

University of Cincinnati, Cincinnati

05091

Neuropsychiatric Associates, Woodstock

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

Duke University

OTHER