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Sponsors and Collaborators: |
The University of Texas Health Science Center at San Antonio Janssen Pharmaceutica N.V., Belgium |
Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00223522 |
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 |
MedlinePlus related topics: | Schizophrenia |
Study Type: | Observational |
Study Design: | Psychosocial, Longitudinal, Random Sample, Prospective Study |
Official Title: | Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data? |
Estimated Enrollment: | 50 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Texas | |||||
UTHSCSA | |||||
San Antonio, Texas, United States, 78229 |
The University of Texas Health Science Center at San Antonio |
Janssen Pharmaceutica N.V., Belgium |
Principal Investigator: | Dawn I Velligan, Ph.D. | UTHSCSA |
Study ID Numbers: | 034-0013-002, 034-0013-002 |
First Received: | September 14, 2005 |
Last Updated: | September 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00223522 |
Health Authority: | United States: Food and Drug Administration |
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