Pediatric Trials Network Long-term Antipsychotic Pediatric Safety Trial (LAPS) NICHD-2016-LAP01 Phase 4 Trial

Pro00084468

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.

2019-01-10

2023-11-21

2023-11-21

Completed

509

Main Study 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 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 Inclusion Criteria: 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. Participant has completed the M24 LAPS Trial Visit

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Main Trial: Obtain whole blood samples for future genetic analyses that may be used to determine if there are any genetic factors that might be used to personalize risk assessments.\n\nRegistry Sub-Study: None.'}, 'enrollmentInfo': {'count': 509, 'type': 'ACTUAL'}}

2024-02-14