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