Bipolar Disorder Clinical Trial
Official title:
Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
Verified date | January 2017 |
Source | Case Western Reserve University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2009 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) - Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be non-adherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days. - BPD of at least 2 years' duration - Treatment with medication to stabilize mood for at least 6 months - A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher Exclusion Criteria: - Unable or unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician - High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current suicidal intent or plan - Inability to speak English - Receiving treatment involuntarily |
Country | Name | City | State |
---|---|---|---|
United States | Connections | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI | An average of 4 hours | ||
Secondary | Hamilton Rating Scale for Depression (HAM-D) | An average of 4 hours | ||
Secondary | Young Mania Rating Scale (YMRS) | An average of 4 hours | ||
Secondary | Brief Psychiatric Rating Scale (BPRS) | An average of 4 hours | ||
Secondary | Clinical Global Impression for Bipolar Disorder (CGI-BP) | An average of 4 hours |
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