Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES) (NCT04143126) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
United States90 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. are between 18-60 years of age;
✓. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
✓. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
✓. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
✓. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
✓. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
✓. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
✓. have had changes to their primary antipsychotic medication within the previous 3 months;
Exclusion criteria
✕. the presence of organic brain syndrome;
✕. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
✕. persistent suicidal or homicidal behavior;
✕. significant clinician-estimated medication non-adherence; and
✕
What they're measuring
1
Change in Persistent Negative Symptoms
Timeframe: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months