Clinical trial NCT00183495: Understanding Treatment Adherence Among Individuals With Bipolar Disorder
Official title: Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression
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: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.

Brief summary: 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.

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 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

Primary outcomes:
measure: Attitudes toward Mood Stabilizers Questionnaire (AMSQ)
timeFrame: Change from Baseline to 6 month visit
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Change from Baseline to 6 month visit
measure: Addiction Severity Index (ASI)
timeFrame: Change from Baseline to 6 month visit
measure: Interpersonal Suppose Evaluation List (ISEL)
timeFrame: Change from Baseline to 6 month visit
measure: Tablets Routine Questionnaire (TRQ)
timeFrame: Change from Baseline to 6 month visit
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Change from Baseline to 6 month visit
Secondary outcomes:
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: Northeast Ohio Health Services
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sajatovic M, Ignacio RV, West JA, Cassidy KA, Safavi R, Kilbourne AM, Blow FC. Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic. Compr Psychiatry. 2009 Mar-Apr;50(2):100-7. doi: 10.1016/j.comppsych.2008.06.008. Epub 2008 Aug 23.
citation: Smilowitz S, Aftab A, Aebi M, Levin J, Tatsuoka C, Sajatovic M. Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder. J Geriatr Psychiatry Neurol. 2020 Sep;33(5):250-255. doi: 10.1177/0891988719874116. Epub 2019 Sep 22.
citation: Sajatovic M, Tatsuoka C, Cassidy KA, Klein PJ, Fuentes-Casiano E, Cage J, Aebi ME, Ramirez LF, Blixen C, Perzynski AT, Bauer MS, Safren SA, Levin JB. A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. J Clin Psychiatry. 2018 Sep 25;79(6):17m12036. doi: 10.4088/JCP.17m12036.
citation: Sajatovic M, Micula-Gondek W, Tatsuoka C, Bialko C. The relationship of gender and gender identity to treatment adherence among individuals with bipolar disorder. Gend Med. 2011 Aug;8(4):261-8. doi: 10.1016/j.genm.2011.06.002. Epub 2011 Jul 16.