Brain Imaging, Cognitive Enhancement and Early Schizophrenia (NCT01561859) | Clinical Trial Compass
CompletedNot Applicable
Brain Imaging, Cognitive Enhancement and Early Schizophrenia
United States102 participantsStarted 2012-06
Plain-language summary
The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. a diagnosis of schizophrenia or schizoaffective disorder verified by the SCID (in our data patients with both conditions respond similarly to CET);
✓. duration since first psychotic symptom of \< 10 years;
✓. stable positive symptoms based on medical record review and SCID for at least 2 months;
✓. are currently maintained on and compliant with prescribed antipsychotic medication;
✓. age 18-55 years;
✓. significant social and cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview utilized in previous CET studies;
✓. current IQ \>= 80; and
✓. the ability to read (sixth grade level or higher) and speak fluent English. This is a study of early course schizophrenia, not first-episode schizophrenia. A duration of illness since first psychotic symptom of \< 10 years is adequate to define the early phase of the illness, particularly given that the average duration of untreated psychosis is a year or more. Eligibility criteria regarding IQ are justified from previous experience with CET indicating that individuals with severe mental incapacity are better served with less cognitively advanced programs.
Exclusion criteria
✕. significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury);
✕. persistent suicidal or homicidal behavior;
What they're measuring
1
Confirm the neuroprotective effects of CET on frontal and temporal brain structure
Timeframe: 18 months
2
Examine the effects of CET on fronto-temporal brain function.
Timeframe: 18 Months
3
Examine the durability of CET effects on fronto-temporal brain structure and function, cognition, and functional outcome at 1 year post-treatment