Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients - Full Text View

Sponsor:	University Hospitals of Cleveland
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00763581

Purpose

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
Bipolar Disorder

Study Type:	Observational
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)

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	20
Study Start Date:	April 2008
Study Completion Date:	January 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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).

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763581

Locations

United States, Ohio
Connections
Cleveland, Ohio, United States, 44122

Sponsors and Collaborators

University Hospitals of Cleveland

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Martha Sajatovic, MD

Case Western Reserve University

More Information

No publications provided

Responsible Party:	Martha Sajatovic, Professor of Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00763581 History of Changes
Other Study ID Numbers:	R34 MH078967-01, R34MH078967-01, R34 MH078967, DAHBR 96-BHA
Study First Received:	September 19, 2008
Last Updated:	November 29, 2011
Health Authority:	United States: Federal Government

Keywords provided by University Hospitals of Cleveland:

Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance

Patient Refusal of Treatment
Treatment Refusal
Refusal of Treatment

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012