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Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
This study is currently recruiting participants.
Study NCT00406718   Information provided by National Institute of Mental Health (NIMH)
First Received: November 30, 2006   Last Updated: March 23, 2009   History of Changes

November 30, 2006
March 23, 2009
November 2006
July 2011   (final data collection date for primary outcome measure)
  • Adherence [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
  • Social and Occupational Functioning Assessment Scale (SOFAS) scores [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
  • Measured at Months 4, 7, and 10: Adherence
  • Social and Occupational Functioning Assessment Scale (SOFAS) scores
Complete list of historical versions of study NCT00406718 on ClinicalTrials.gov Archive Site
  • Schizophrenia symptoms [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
  • Functioning [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
  • Treatment outcome [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
  • Measured at Months 4, 7, and 10: Schizophrenia symptoms
  • Functioning
  • Treatment outcome
 
Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia

This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia.

Schizophrenia is a severely debilitating mental disorder. People with schizophrenia often experience unusual thoughts or perceptions, decreased pleasure in everyday life, and difficulty functioning in social situations. Antipsychotic medications have been shown to be effective in improving the symptoms of schizophrenia. Poor adherence to medication, however, leads to re-hospitalization, impedes the process of recovery, and contributes to the high costs associated with schizophrenia treatment. Studies have shown that PharmCAT, cognitive adaptive training that specifically targets medication adherence, has been effective in improving adherence and outcomes in people with schizophrenia. The Med-eMonitor™ is a new pill device that is able to alert patients when they should take medication, when they are taking the wrong medication, and when they are taking medication at the wrong time. The device can also record side effect complaints and then send stored information to treatment staff. The capabilities of the Med-eMonitor™ eliminate the need for the weekly home visits that are necessary in the PharmCAT program, and may make treatment more easily available to individuals in remote or rural settings. This study will compare the effectiveness of PharmCAT, the Med-eMonitor™, and standard treatment in improving medication adherence and treatment outcome in people with schizophrenia.

Participants in this study will be randomly assigned to one of the following treatment groups: (1) PharmCAT; (2) the Med-eMonitor™; or (3) standard treatment. Participants in Group 1 will receive weekly home visits from a case manager. These visits will specifically target medication adherence. Participants in Group 2 will use the Med-eMonitor™ device. Data recorded by the device will be sent electronically to study staff. Participants in Group 3 will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function. The device will record only when medication is taken. All participants will report to the study site at study entry and Months 4, 7, and 10 for measures of symptoms, functioning, social activities, and relationships.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Schizophrenia
  • Schizoaffective Disorder
  • Device: Med-eMonitor Device
  • Procedure: PharmCAT Therapy
  • Behavioral: Standard treatment
  • Experimental: Participants will receive PharmCAT
  • Active Comparator: Participants will receive the Med-eMonitor™
  • Active Comparator: Participants will receive standard treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria, as determined on the basis of the Structured Clinical Interview for Diagnosis (SCID-P)
  • Receiving treatment with an oral atypical antipsychotic medication other than clozapine (e.g., risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or others as they are FDA approved)
  • Assumes some responsibility for taking own medications
  • Able to provide evidence of a stable living environment (e.g., individual apartment, family home, or board and care facility) within 3 months prior to study entry and no plans to move in the next year
  • Intact visual and auditory ability as determined by a computerized screening battery
  • Ability to read at the 5th grade level or higher based upon score on the Wide Range Achievement Test (WRAT)
  • Able to understand and complete rating scales and neuropsychological testing
  • Working telephone present in the home

Exclusion Criteria:

  • History of significant head trauma, seizure disorder, or mental retardation
  • Alcohol or drug abuse or dependence within 3 months prior to study entry
  • Currently being treated by an assertive community treatment (ACT) team
  • History of violence within 1 year prior to study entry
  • Any hospitalizations within 3 months prior to study entry
Both
18 Years to 60 Years
No
Contact: Natalie J. Maples, MA 210-562-5250 maplesn@uthscsa.edu
Contact: Monica Mery 210-562-5253
United States
 
NCT00406718
Dawn I. Velligan, PhD, UTHSCSA
R01 MH074047, DAHBR 96-BHA
National Institute of Mental Health (NIMH)
 
Principal Investigator: Dawn I. Velligan, PhD The University of Texas Health Science Center at San Antonio (UTHSCSA)
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP