Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

NCT00763581 | Completed DMC

• 3 other identifiers: R34MH078967-01R34MH078967DAHBR 96-BHA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

Patient Non-Adherence; Patient Non-Compliance; Patient Nonadherence; Patient Noncompliance; Patient Refusal of Treatment; Treatment Refusal; Refusal of Treatment

Outcome Measures

Primary Outcomes (1)

• Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI

  An average of 4 hours

Secondary Outcomes (4)

• Hamilton Rating Scale for Depression (HAM-D)

  An average of 4 hours

• Young Mania Rating Scale (YMRS)

  An average of 4 hours

• Brief Psychiatric Rating Scale (BPRS)

  An average of 4 hours

• Clinical Global Impression for Bipolar Disorder (CGI-BP)

  An average of 4 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty adults (10 men and 10 women) receiving standard outpatient mental health treatment at Connections, a community mental health clinic (CMHC).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Connections

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Patient Compliance; Treatment Refusal

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: October 1, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)