Understanding Treatment Adherence Among Individuals With Bipolar Disorder
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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 |
- 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) |
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 |
Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.
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| United States, Ohio | |
| Northeast Ohio Health Services | |
| Beachwood, Ohio, United States, 44122 | |
| 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, DAHBR 9K-TA |
| Study First Received: | September 13, 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 16, 2013