Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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 increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.

Key facts

Study ID

NCT04348604

Run by

Case Western Reserve University

People needed

36

Starts

2021-03-15

Expected to finish

2023-09-01

Last updated by the study team

2026-06-24

Who can join

Age: 14 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve Universty — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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