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Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763581
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : February 1, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University

Brief Summary:
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.

Condition or disease
Bipolar Disorder

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
Study Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Primary Outcome Measures :
  1. Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI [ Time Frame: An average of 4 hours ]

Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: An average of 4 hours ]
  2. Young Mania Rating Scale (YMRS) [ Time Frame: An average of 4 hours ]
  3. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: An average of 4 hours ]
  4. Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: An average of 4 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty adults (10 men and 10 women) receiving standard outpatient mental health treatment at Connections, a community mental health clinic (CMHC).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763581

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United States, Ohio
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Case Western Reserve University
National Institute of Mental Health (NIMH)
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Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
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Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University Identifier: NCT00763581    
Other Study ID Numbers: R34MH078967-01 ( U.S. NIH Grant/Contract )
R34MH078967-01 ( U.S. NIH Grant/Contract )
R34MH078967 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Keywords provided by Martha Sajatovic, MD, Case Western Reserve University:
Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance
Patient Refusal of Treatment
Treatment Refusal
Refusal of Treatment
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders