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Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763581
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University

Tracking Information
First Submitted Date September 19, 2008
First Posted Date October 1, 2008
Last Update Posted Date February 1, 2017
Study Start Date April 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2011)
Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI [ Time Frame: An average of 4 hours ]
Original Primary Outcome Measures
 (submitted: September 29, 2008)
Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI [ Time Frame: Measured at a single visit ]
Change History
Current Secondary Outcome Measures
 (submitted: November 29, 2011)
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: An average of 4 hours ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: An average of 4 hours ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: An average of 4 hours ]
  • Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: An average of 4 hours ]
Original Secondary Outcome Measures
 (submitted: September 29, 2008)
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Measured at a single visit ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: Measured at a single visit ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at a single visit ]
  • Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: Measured at a single visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients
Official Title Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2008)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00763581
Other Study ID Numbers R34MH078967-01( U.S. NIH Grant/Contract )
R34MH078967-01 ( U.S. NIH Grant/Contract )
R34MH078967 ( U.S. NIH Grant/Contract )
DAHBR 96-BHA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martha Sajatovic, MD, Case Western Reserve University
Study Sponsor Case Western Reserve University
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
PRS Account Case Western Reserve University
Verification Date January 2017