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Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00183703
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 2, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Case Western Reserve University

Brief Summary:
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.

Condition or disease
Bipolar Disorder

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
Study Start Date : July 2004
Primary Completion Date : November 2006
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Participants with rapid cycling bipolar disorder (RCBPD)

Primary Outcome Measures :
  1. 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 [ Time Frame: Measured at one study visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.

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

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 ClinicalTrials.gov identifier (NCT number): NCT00183703

United States, Ohio
Northeast Ohio Health Services
Beachwood, Ohio, United States, 44122
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
National Institute of Mental Health (NIMH)
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine

Responsible Party: Martha Sajatovic MD, Professor of Psychiatry, Case Western Reserve University School of Medicine
ClinicalTrials.gov Identifier: NCT00183703     History of Changes
Other Study ID Numbers: K23MH065599-02 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: June 2013

Keywords provided by Case Western Reserve University:
Depression, Bipolar
Manic-Depressive Psychosis

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders