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CompletedNCT00223522Updated Sep 22, 2005

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

An observational study in Schizophrenia and Schizoaffective, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2005-09-22.

Sponsored by The University of Texas Health Science Center at San Antonio · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective

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Keywords

  • Schizophrenia
  • Schizoaffective
  • MEMS
  • adherence to antipsychotic medication
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 50 is below the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Time perspective
Prospective
Enrollment
50 participants

Interventions

  • DeviceMEMS caps
06

Study locations

1 site
  • UTHSCSA
    San Antonio, Texas 78229, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00223522
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Janssen Pharmaceutica N.V., Belgium
First posted
Sep 22, 2005
Start date
Apr 2004
Completion
Mar 2005
Last update
Sep 22, 2005

Study contacts

Dawn I Velligan, Ph.D.
principal investigator · University of Texas
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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