Long-term Antipsychotic Pediatric Safety Trial

NCT ID: NCT03522168

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 509 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2023-11-21

Brief Summary

Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality.

An additional sub-study (registry sub-study) was added via a protocol amendment. This registry sub-study is optional for participants and only participants who participate in the main study are eligible if they were 6 to less than 18 years of age at the time of the M0 visit. Participants who consent to this registry sub-study will participate in yearly in-person visits and complete monthly assessments remotely over the course of two additional years from the time of their final visit of the main LAP01 study.

Detailed Description

Main LAP01 study: Prospective, multi-site, Phase 4, longitudinal observational study designed to systematically collect robust longitudinal post-marketing safety and quality of life data about multi-year pediatric treatment with risperidone or aripiprazole. Screening may occur for up to 37 days prior to enrollment. Assessments will occur at in-person visits planned at months 0, 6, 12, 18 and 24, and at unscheduled, in-person visits that study staff request when the participant switches or stops antipsychotic monotherapy with risperidone or aripiprazole, adds or stops treatment with a weight modifying agent, becomes pregnant, chooses to withdraw from the study prematurely or, has an ongoing Serious Adverse Event (SAE) that requires further assessment. Monthly remote interim contacts occurring between in-person visits will monitor for changes (other than dose related) in antipsychotic therapy or weight modifying treatments, potential SAEs, and potential pregnancy. The participant, his/her parent/guardian, and the participant's personal psychotropic-prescribing medical provider (PPPMP) will make any and all decisions related to antipsychotic medications, any other medications, and the participant's current mental state, developmental/psychiatric condition, and level of risk for potential harm to self or others independent of the study procedures and assessments. Study staff (SS) will share with the participant's PPPMP all lab results and changes in the participant's AEs or clinical presentation, which the study medical clinician (SMC) considers medically concerning based on the participant's assessment during in-person visits. If an emergency safety concern is evident during an in-person visit, the SMC will immediately assess the participant, following medical standard-of-care procedures, to determine whether the participant is safe to leave the clinic or requires additional emergency care. If new or worsening symptoms are reported by the participant or parent/guardian during remote interim contacts, the participant and/or parent/guardian will be instructed to contact the PPPMP directly.

Registry sub-study: Participants who choose to participate will consent via a mobile application (Pattern Health) and will measure their height and weight at home monthly (also collected through the Pattern Health mobile application). One questionnaire will be completed every 6 months via the Pattern Health mobile application. Yearly in-person visits will be conducted to obtain in-clinic height, weight, vital signs and review concomitant medications.

Conditions

Weight, Body

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Risperidone group

Risperidone, n=350, including 30 children 3 - \<6 years old and 320 children 6 - \<18 years old. \~50% - \~80% of the entire group will have \<90 days of prior treatment with any antipsychotic.

Risperidone

Intervention Type: DRUG

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

Aripiprazole group

Aripiprazole group, n=350, including 30 children 3 - \<6 years old and 320 children 6 - \<18 years old. \~50% - \~80% of the entire group will have ≤90 days of prior treatment with any antipsychotic.

Aripiprazole

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Risperdal; Abilify

Eligibility Criteria

Inclusion Criteria

1. Parent/guardian has provided informed consent

2. Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB)

3. 3 - <18 years of age inclusive at time of M0 visit

4. Participant, when developmentally appropriate, and parent/guardian are:

1. Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider

2. Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP

5. Based on their age at the time of M0 visit, participant is receiving aripiprazole or risperidone at the dose and for the diagnoses as listed below:

1. Participants ages 3 - < 6 years can have any diagnosis and any dose

2. Participants ages ≥ 6 - <18 years at the doses and for the diagnoses listed below

Labeled Indications (Closely Related Disorders)

Aripiprazole 2-30 mg/day

• Irritability associated with autistic disorder:

(Irritability in autism spectrum disorder) - Treatment of Tourette's disorder: (Tourette's disorder, persistent (chronic) motor or vocal tic disorder)

• Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar l disorder: (Bipolar spectrum disorders including disruptive mood dysregulation disorder)

• Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder)

Risperidone 0.25-6 mg/day - Irritability associated with autistic disorder: (Irritability in autism spectrum disorder)

• Bipolar Mania: (Bipolar spectrum disorders including disruptive mood dysregulation disorder)

• Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder)
• MYCITE® (aripiprazole) and all forms of injectables are not permitted in this study

6. Guardian anticipates risperidone or aripiprazole treatment will continue for ≥6 months

1. Enrolled in LAPS Trial

2. Access to a personal mobile device (with Bluetooth capability and data or internet access) and willing to use it for the purposes of this study

3. Parent/guardian/LAR/participant has provided informed consent

4. Participant has provided assent/consent if developmentally appropriate and as required by the institutional review board (IRB)

5. Participant was part of the 6 to <18 year-old group in the LAPS Trial

Exclusion Criteria

1. History of prior or current diagnosis of an eating disorder or meets diagnostic criteria for an eating disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and determined by psychiatric exam

2. Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems

3. Known or self-reported pregnancy

4. Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit

5. Contraindications to participation in the study in the opinion of the SMC

6. Unwilling or unable to provide back-up family contact information

Registry Sub-Study

1. Participant has completed the M24 LAPS Trial Visit

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Benjamin

Kiser-Arena Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linmarie Sikich, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institution (DCRI)

Kevin Watt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Karan Kumar, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institution (DCRI)

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Harmonex Neuroscience Research

Dothan, Alabama, United States

Southwest Autism Research & Resource Center

Phoenix, Arizona, United States

Arkansas Children's Research Institute

Little Rock, Arkansas, United States

OM Research

Lancaster, California, United States

UCLA Semel Institute

Los Angeles, California, United States

Yale Child Study Center

New Haven, Connecticut, United States

Clinical Trials Solution

Miami, Florida, United States

South Florida Behavioral Health Network

Miami, Florida, United States

Scientific Clinical Research, Inc.

North Miami, Florida, United States

Valley Healthcare System

Columbus, Georgia, United States

IACT Health

Grayson, Georgia, United States

Attalla Consultants LLC dba Institute for Behavioral Medicine

Smyrna, Georgia, United States

AMR-Baber Research, Inc.

Naperville, Illinois, United States

Beacon Medical Group

South Bend, Indiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital, Lurie Center for Autism

Lexington, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield, Michigan, United States

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke Child and Family Study Center

Durham, North Carolina, United States

Behavioral Health Hospital Oupatient Clinic

Greensboro, North Carolina, United States

Cone Health Outpatient Behavioral Health

Greensboro, North Carolina, United States

Carolina Partners in Mental HealthCare, PLLC

Raleigh, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Avera McKennan University Psychiatry Associates

Sioux Falls, South Dakota, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

BioBehavioral Research of Austin

Austin, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Neuropsychiatric Associates

Woodstock, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00084468

Identifier Type: -

Identifier Source: org_study_id