Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)

Conditions
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Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be non-adherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days. BPD of at least 2 years' duration Treatment with medication to stabilize mood for at least 6 months A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher Exclusion Criteria: Unable or unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current suicidal intent or plan Inability to speak English Receiving treatment involuntarily

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI |  | An average of 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) |  | An average of 4 hours | 
| Young Mania Rating Scale (YMRS) |  | An average of 4 hours | 
| Brief Psychiatric Rating Scale (BPRS) |  | An average of 4 hours | 
| Clinical Global Impression for Bipolar Disorder (CGI-BP) |  | An average of 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Treatment Refusal, Refusal of Treatment