N/A Completed N=85 Randomized Single-blind Treatment

Improving Basic and Social Cognition in Veterans With Schizophrenia

schizoaffective disorder · Schizophrenia

Source: ClinicalTrials.gov NCT00470106 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Apr 2016

Primary outcomePrimary: Mean Test Scores for Facial Emotion Identification. — 45.5; 41.1; 43.8; 45.1 number of correct answers — p=<.001

Summary

Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Test Scores for Facial Emotion Identification.	45.5; 41.1; 43.8; 45.1	<.001 sig
SECONDARY Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).	3.43; 3.57; 3.35; 3.19	<.10

Eligibility Criteria

Inclusion Criteria

All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified according to Diagnosis and Statistical Manual-IV criteria.
In addition, the subjects will meet the following criteria:
Between 18 and 60 years of age
Estimated premorbid intelligence quotient > 70 (based on reading ability)
Understand spoken English sufficiently to comprehend testing procedures
Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 6 weeks prior to enrollment, and none anticipated for the 3 months of participation)

Exclusion Criteria

No clinically significant neurological disease as determined by medical history
No history of serious head injury (e.g., loss of consciousness longer than 1 hour)
No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing
The patients psychotic experiences can be explained solely by the use of drugs or alcohol

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Data sourced from ClinicalTrials.gov (NCT00470106). 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. Informational only — not medical advice.