Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

NCT ID: NCT00183703

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-08-31

Brief Summary

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This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.

Detailed Description

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Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with RCBPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.

This study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Qualitative Interview

Participants with rapid cycling bipolar disorder (RCBPD)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 years prior to study entry
* Has experienced an index depressive episode
* Received treatment with medication to stabilize mood for at least 6 months prior to study entry
* Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

Exclusion Criteria

* Unable/unwilling to participate in psychiatric interviews
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic, MD

Professor of Psychiatry and of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine

Locations

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Northeast Ohio Health Services

Beachwood, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Sajatovic M, Jenkins JH, Cassidy KA, Muzina DJ. Medication treatment perceptions, concerns and expectations among depressed individuals with Type I Bipolar Disorder. J Affect Disord. 2009 Jun;115(3):360-6. doi: 10.1016/j.jad.2008.10.002. Epub 2008 Nov 8.

Reference Type RESULT
PMID: 18996600 (View on PubMed)

Sajatovic M, Jenkins JH, Safavi R, West JA, Cassidy KA, Meyer WJ, Calabrese JR. Personal and societal construction of illness among individuals with rapid-cycling bipolar disorder: a life-trajectory perspective. Am J Geriatr Psychiatry. 2008 Sep;16(9):718-26. doi: 10.1097/JGP.0b013e3180488346. Epub 2007 Dec 10.

Reference Type RESULT
PMID: 18070834 (View on PubMed)

Other Identifiers

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K23MH065599-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23MH065599-02

Identifier Type: NIH

Identifier Source: org_study_id

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