Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT03522168
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT03522168
Study Brief:
Protocol Section:
NCT03522168