Last updated on May 2020

Long-term Antipsychotic Pediatric Safety Trial


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Body Weight
  • Age: Between 3 - 18 Years
  • Gender: Male or Female

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:
  5. Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider
  6. Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP
  7. 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:
  8. Participants ages 3 - < 6 years can have any diagnosis and any dose
  9. 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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