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Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183703
First received: September 14, 2005
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2004
Study Completion Date: August 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants with rapid cycling bipolar disorder (RCBPD)

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.

  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

The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183703

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

Publications:

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: K23 MH065599-02, DAHBR 9K-TA
Study First Received: September 14, 2005
Last Updated: January 22, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depression, Bipolar
Manic-Depressive Psychosis

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013