Understanding Treatment Adherence Among Individuals With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00183495
First received: September 13, 2005
Last updated: July 1, 2013
Last verified: June 2013
  Purpose

This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence [ Time Frame: Measured three times over 6 months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: March 2004
Study Completion Date: August 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. 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 BPD 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 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; 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

Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of bipolar disorder type I for at least two 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
  • Able to participate in psychiatric interviews
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183495

Locations
United States, Ohio
Northeast Ohio Health Services
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
Case Western Reserve University
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: NCT00183495     History of Changes
Other Study ID Numbers: K23 MH065599-01, K23MH065599-01, DAHBR 9K-TA
Study First Received: September 13, 2005
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 23, 2014