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

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ClinicalTrials.gov Identifier: NCT00223522
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
The University of Texas Health Science Center at San Antonio

Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Schizoaffective Device: MEMS caps

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Allocation: Random Sample
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?
Study Start Date : April 2004
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00223522     History of Changes
Other Study ID Numbers: 034-0013-002
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs