Long-term Antipsychotic Pediatric Safety Trial
Condition: Weight, Body
MeSH terms: Body Weight
Study type: Observational

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.
    

Intervention name(s): Risperidone; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): Risperdal; Abilify
Intervention MeSH terms: Risperidone; Aripiprazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Main Study:

        The study population will consist of two groups of children 3 - <18 yrs old at the M0
        visit:

          -  Risperidone group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 -
             <18 yrs old, ~ 50% - 80% will have <90 days of prior treatment with any antipsychotic.

          -  Aripiprazole group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 -
             <18 yrs old., ~ 50% - 80% will have ≤90 days of prior treatment with any
             antipsychotic.

        We will target participants within each treatment group to be distributed across the age
        range to permit analyses of age effects with:

          -  ~30 being 3 - <6 years

          -  ≥35% (n ≥123) being 6 - <12 years

          -  ≥35% (n ≥123) being 12 - <18 years PK sub group at selected sites includes 24
             participates, details in protocol.

        Registry Sub-Study Registry participants will be selected exclusively from the population
        that has enrolled onto the LAPS Trial.
      
Biospecimen 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.

      Registry Sub-Study: None.