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Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00763581
  Purpose

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.


Condition
Bipolar Disorder

MedlinePlus related topics:   Bipolar Disorder   

Drug Information available for:   Disulfiram   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Cross-Sectional
Official Title:   Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
  • Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   20
Study Start Date:   April 2008
Estimated Study Completion Date:   January 2009
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

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 non-adherence. Nine in ten individuals with BPD has 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 non-adherence, 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 one and a half and three hours. All participants will have a history of medication non-adherence. 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Twenty adults (10 men and 10 women) receiving standard outpatient mental health treatment at a Community Mental Health Clinic (CMHC), Connections.


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 non-adherence will be identified with 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 non-adherence will be identified via a clinician version of the TRQ to identify non-adherence of 30% or more over the past 30 days.
  • BPD for 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 for 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763581

Contacts
Contact: Kristin Cassidy, MA     216-844-2834     kristin.cassidy@uhhospitals.org    
Contact: Edna Fuentes-Casiano, BSW     216-844-2104     edna.fuentes-casiano@uhhospitals.org    

Locations
United States, Ohio
Connections     Recruiting
      Cleveland, Ohio, United States, 44122
      Contact: Edna Fuentes-Casiano, BSW     216-844-2104     Edna.Fuentes-Casiano@uhhospitals.org    
      Contact: Kristin Cassidy, MA     216-844-2834     Kristin.Cassidy@uhhospitals.org    
      Principal Investigator: Martha Sajatovic, MD            
      Sub-Investigator: Jennifer Levin, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Martha Sajatovic, MD     Case Western Reserve University    
  More Information


Responsible Party:   Case Western Reserve University ( Martha Sajatovic, MD )
Study ID Numbers:   R34 MH078967-P1, R34 MH078967, DAHBR 96-BHA
First Received:   September 19, 2008
Last Updated:   September 29, 2008
ClinicalTrials.gov Identifier:   NCT00763581
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Patient Non-Adherence  
Patient Non-Compliance  
Patient Nonadherence  
Patient Noncompliance  
Patient Refusal of Treatment
Treatment Refusal
Refusal of Treatment

Study placed in the following topic categories:
Disulfiram
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on November 20, 2008




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