Long-term Antipsychotic Pediatric Safety Trial

  • days left to enroll
  • participants needed
  • sponsor
    Duke University
Updated on 25 February 2021
Lee Howard
Primary Contact
Arkansas Children's Research Institute (2.3 mi away) Contact
+39 other location


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.


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 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, with the participant's PPPMP. 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.

Condition Body Weight
Treatment risperidone, Aripiprazole
Clinical Study IdentifierNCT03522168
SponsorDuke University
Last Modified on25 February 2021


Yes No Not Sure

Inclusion Criteria

Parent/guardian has provided informed consent
Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB)
3 - <18 years of age inclusive at time of M0 visit
Participant, when developmentally appropriate, and parent/guardian are
Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider
Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP
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
Participants ages 3 - < 6 years can have any diagnosis and any dose
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

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
Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems
Known or self-reported pregnancy
Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit
Contraindications to participation in the study in the opinion of the SMC
Unwilling or unable to provide back-up family contact information
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