Clinical trial NCT00183703: Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder
Official title: Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Depression, Bipolar
Manic-Depressive Psychosis
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: The Subjective Experience of Medication Interview (SEMI)
timeFrame: Baseline
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: Baseline
measure: Clinical Global Impression (CGI)
timeFrame: Baseline
measure: Insight and Treatment Attitudes Questionnaire (ITAQ)
timeFrame: Baseline
measure: Illness Behavior Questionnaire (IBQ)
timeFrame: Baseline
measure: Attitude Towards Mood Stabilizers Questionnaire (AMSQ)
timeFrame: Baseline
measure: Multidimensional Health Locus of Control Scale (MHLC)
timeFrame: Baseline
measure: Treatment Adherence
timeFrame: Baseline
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: Northeast Ohio Health Services
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.