Medication Adherence in Older People With Psychosis

May 3, 2013 updated by: Veterans Medical Research Foundation

Medication Adherence in Older Psychotic People

This study will determine whether Medication Adherence Therapy (MAT) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis.

Study Overview

Detailed Description

Psychoses are among the most common and serious psychiatric disorders. Currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. Unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. Nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization.

Participants in this study are randomly assigned to receive either MAT or supportive treatment for 12 weeks. MAT is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. Individual MAT sessions are held in Weeks 1 and 12; small group sessions take place in Weeks 2 through 11. Three monthly booster group sessions begin in Week 16. Participants are assessed at baseline and at 3, 6, and 12 months. Medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92161
        • Division of Geriatric Psychiatry Center (University of California, San Diego)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Outpatient status at the time of enrollment
  • Currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jonathan Lacro, PharmD, VA San Diego Healthcare System & University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

October 29, 2003

First Submitted That Met QC Criteria

October 29, 2003

First Posted (Estimate)

October 30, 2003

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH062849 (U.S. NIH Grant/Contract)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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