Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

Bipolar Disorder Clinical Trial

Official title:

Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763581
• Other study ID #: R34MH078967-01
• Secondary ID: R34MH078967-01R3
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: January 31, 2017
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2017
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with approximately half of those relapses occurring in the first 2 years after remission. High rates of relapse and no substantial improvements in illness outcomes for many patients despite advances in drug treatment may be related to a common problem: medication nonadherence. Nine in 10 individuals with BPD have seriously considered medication withdrawal, and one third of individuals with BDP do not take 30% or more of their prescribed medications. The researchers in this study will identify BPD patients who do not take their medications as prescribed and conduct interviews with them. By obtaining an understanding of subjective reasons for medication nonadherence, this study will pave the way for better interventions to ensure BDP patients take the medications that will help them.

Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours. All participants will have a history of medication nonadherence. Participants will be asked to fill out questionnaires and undergo a structured interview with a researcher. The interview will be audio recorded. The questionnaires and interview will assess BPD symptoms, attitudes toward medications, and to what extent patients are taking their medications. Researchers will also measure the number of pills used in participants' prescriptions by counting how many pills are left in each prescription bottle.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Locations

Country	Name	City	State
United States	Connections	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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