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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00223522
Enrollment
50
Registered
2005-09-22
Start date
2004-04-30
Completion date
2005-03-31
Last updated
2005-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective, Schizophrenia

Keywords

Schizophrenia, Schizoaffective, MEMS, adherence to antipsychotic medication

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.

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.

Interventions

DEVICEMEMS caps

Sponsors

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

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026