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Active Not Recruiting NCT04143126

Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

Conditions: Schizophrenia

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: University of Pittsburgh

Location: University of Pittsburgh Pittsburgh Pennsylvania

Summary

This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.

Eligibility Criteria

Inclusion Criteria: Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and: 1. are between 18-60 years of age; 2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID; 3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record; 4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period; 5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period; 6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period; 7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period; 8. have had changes to their primary antipsychotic medication within the previous 3 months; 9. have current IQ \> 80; and 10. are able to read (sixth grade level or higher) and speak fluent English. - Exclusion Criteria: Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include: 1. the presence of organic brain syndrome; 2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness); 3. persistent suicidal or homicidal behavior; 4. significant clinician-estimated medication non-adherence; and 5. SCID-verified substance use disorder.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04143126). StuddyBuddy aggregates publicly available trial information.