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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223522
• Other study ID #: 034-0013-002
• Secondary ID: 034-0013-002
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: April 2004
• Est. completion date: March 2005

Study information

• Verified date: September 2005
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Random Sample, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Schizoaffective
• Schizophrenia

Intervention

Device:
• MEMS caps

Locations

Country	Name	City	State
United States	UTHSCSA	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

United States,