Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223522
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.


Condition Intervention
Schizophrenia
Schizoaffective
Device: MEMS caps

Study Type: Observational
Study Design: Allocation: Random Sample
Time Perspective: Longitudinal
Official Title: Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Estimated Enrollment: 50
Study Start Date: April 2004
Estimated Study Completion Date: March 2005
Detailed Description:

Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Schizophrenia or Schizoaffective disorder
  • Between the ages of 18-55
  • no documented history of head injury, mental retardation or neurological disorder
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00223522

Locations
United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Janssen Pharmaceutica N.V., Belgium
Investigators
Principal Investigator: Dawn I Velligan, Ph.D. University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223522     History of Changes
Other Study ID Numbers: 034-0013-002, 034-0013-002
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Schizophrenia
Schizoaffective
MEMS
adherence to antipsychotic medication

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014