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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT04348604
Eligibility Criteria:
Inclusion Criteria:
* DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5)
* Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month
* If \< 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if \> 18 years, able and willing to provide written informed consent
* Fluent in English
Exclusion Criteria:
* Unable to receive care in the outpatient setting due to illness severity
* A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder
* Documented or suspected IQ \< 70
* Prior enrollment in CAE or Phase 2
* Have recently (in the past month) started a new psychotherapy/behavioral intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
21 Years
Study:
NCT04348604
Study Brief:
Protocol Section:
NCT04348604