Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)|
- Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI [ Time Frame: An average of 4 hours ] [ Designated as safety issue: No ]
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: An average of 4 hours ] [ Designated as safety issue: No ]
- Young Mania Rating Scale (YMRS) [ Time Frame: An average of 4 hours ] [ Designated as safety issue: No ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: An average of 4 hours ] [ Designated as safety issue: No ]
- Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: An average of 4 hours ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with approximately half of those relapses occurring in the first 2 years after remission. High rates of relapse and no substantial improvements in illness outcomes for many patients despite advances in drug treatment may be related to a common problem: medication nonadherence. Nine in 10 individuals with BPD have seriously considered medication withdrawal, and one third of individuals with BDP do not take 30% or more of their prescribed medications. The researchers in this study will identify BPD patients who do not take their medications as prescribed and conduct interviews with them. By obtaining an understanding of subjective reasons for medication nonadherence, this study will pave the way for better interventions to ensure BDP patients take the medications that will help them.
Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours. All participants will have a history of medication nonadherence. Participants will be asked to fill out questionnaires and undergo a structured interview with a researcher. The interview will be audio recorded. The questionnaires and interview will assess BPD symptoms, attitudes toward medications, and to what extent patients are taking their medications. Researchers will also measure the number of pills used in participants' prescriptions by counting how many pills are left in each prescription bottle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763581
|United States, Ohio|
|Cleveland, Ohio, United States, 44122|
|Principal Investigator:||Martha Sajatovic, MD||Case Western Reserve University|