Status:
COMPLETED
Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatm...
Detailed Description
This study is a pilot, prospective project of the effects of customized adherence enhancement (CAE) when added to the medical management (usual care) of outpatients with bipolar disorder (BPD) who are...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Bipolar Disorder (BPD) Type I or Type II determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (Sheehan 1998);
- Demonstrated history of poor adherence as per either self-report or clinician report. In this study, self-reported treatment non-adherence will be identified with Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 20% or more of medication within either the past week or past month (those missing 20% or more within past week will be considered to be non-adherent over the past month).
- BPD for at least two years duration;
- Treatment with atypical antipsychotic medication to stabilize mood for at least six months;
- The ability to participate in psychiatric interviews and to give written, informed consent for study participation; and
- Age 18 or older.
Exclusion
- Unable/unwilling to participate in psychiatric interviews based on the clinical opinion of the investigator or the treating clinician. Individuals who are grossly psychotic may be excluded at this point if the treating clinician feels that the prospective participant is unable to participate in the interviews or study procedures;
- Unable/unwilling to give written, informed consent to study participation;
- High risk for suicide (e.g., active suicidal ideation and recent suicide attempt; active suicidal ideation and current intent or plan). In the interest of patient safety, individuals who are acutely suicidal will be excluded from study participation; or
- Individuals who are non-English speaking will be excluded as study assessment tools are not available in other languages and would be impractical to develop in this small, exploratory study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00830310
Start Date
January 1 2009
End Date
October 1 2010
Last Update
December 30 2014
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106