N/A
N=142
Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00406718 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Adherence — 91.84; 88.61; 72.55 Percentage of medication taken
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Med-eMonitor (Behavioral); PharmCAT (Behavioral); Treatment as Usual (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
91.84; 88.61; 72.55 | — |
| PRIMARY Social and Occupational Functioning Assessment Scale (SOFAS) Scores |
91.84; 88.61; 73.19 | — |
| SECONDARY Schizophrenia Symptoms |
2.73; 2.75; 2.72 | — |
Summary
This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00406718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.