Phase 4
N=60
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00333177 ↗Enrolled (actual)
60
Serious AEs
8.9%
Results posted
Mar 2020
Primary outcome: Primary: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) — 6.7; 0.9; 3.9; 5.9 T scores — p=<0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cognitive remediation training (CT) (Behavioral); Healthy behavior training (HBT) (Behavioral); Risperidone, administered orally (Oral Ris) (Drug); Risperidone, administered via injection (RLAI) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) |
6.7; 0.9; 3.9; 5.9 | <0.03 sig |
| PRIMARY Work/School Functioning (Global Functioning Scale: Role) |
2.70; 1.69; 2.43; 0.18 | <.05 sig |
| PRIMARY Average Medication Non-adherence |
1.0; 1.9 | .001 sig |
| PRIMARY Work/School Functioning (Global Functioning Scale: Role) |
2.70; 1.69; 2.43; 0.18 | <.05 sig |
| SECONDARY Work Behavior Inventory (WBI) Quality of Work/School Performance |
-6.5; 8.8; -3.4; 0.0 | 0.55 |
| SECONDARY Maintenance of Work/School Attendance |
35.4; 24.4; 26.7; 12.0 | <0.02 sig |
| SECONDARY Exacerbation or Relapse of Psychotic Symptoms |
2; 10 | <0.01 sig |
| SECONDARY Retention in Treatment |
359.7; 352.2; 332.4; 348.3 | <.05 sig |
| SECONDARY Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) |
1.25; 3.29; 2.00; 3.75 | <.02 sig |
| SECONDARY Change in Motivation for Work/School |
3.7; 1.2; -2.4; -1.9 | =.053 |
| SECONDARY Change in Coping Strategies |
— | — |
Summary
This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study entry
Exclusion Criteria
- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
- Mental retardation (e.g., premorbid intelligence quotient (IQ) less than 70)
- Significant alcohol or substance use during last 6 months
- Unable to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
Data sourced from ClinicalTrials.gov (NCT00333177). 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.