Long-term Antipsychotic Pediatric Safety Trial (LAPS)

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.

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