Status:
COMPLETED
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Lead Sponsor:
Case Western Reserve University
Conditions:
Bipolar Disorder
Eligibility:
All Genders
14-21 years
Phase:
NA
Brief Summary
Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04348604
Start Date
March 15 2021
End Date
September 1 2023
Last Update
October 10 2024
Active Locations (2)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
2
Case Western Reserve Universty
Cleveland, Ohio, United States, 44106