Customized Medication Adherence Enhancement for Adults With Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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 treatment adherence problems.

Key facts

Study ID

NCT00830310

Run by

University Hospitals Cleveland Medical Center

People needed

43

Starts

2009-01-01

Expected to finish

2010-10-01

Last updated by the study team

2014-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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