Overview

This trial is active, not recruiting.

Condition chronic schizophrenia
Treatments cognitive remediation therapy, comt genotyping
Sponsor Manhattan Psychiatric Center
Collaborator National Institute of Mental Health (NIMH)
Start date April 2007
End date January 2015
Trial size 142 participants
Trial identifier NCT00664274, 061/C39-0, 1R03MH078098-01, MRPC 2917

Summary

This project will explore the relationship between catechol-O-methyltransferase (COMT) Val158/108Met genotype and response to a 12-week computerized neurocognitive rehabilitation (CRT) given to chronic schizophrenic patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Other)
cognitive remediation therapy educational and behavioral training techniques
36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.
comt genotyping COMT polymorphism
One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.

Primary Outcomes

Measure
To evaluate the effect of the association of COMT Val108/158 Met genotype with the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
time frame: 12 weeks

Secondary Outcomes

Measure
To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.
time frame: 12 weeks
To assess the differences in demographic variables (e.g. ethnicity, intellectual functioning as measured by WRAT III Reading test, and age) with response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
time frame: 12 weeks
To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: 1. Participation in the active arm of the neurocognitive remediation program 2. Age 18 - 55 3. Inpatients 4. DSM-IV diagnosis of schizophrenia (all subtypes) with illness duration >5 years 5. Auditory and visual acuity adequate to complete cognitive tests 6. Stable dose of oral atypical antipsychotic for at least 4 weeks 7. Total PANSS score > 60 8. RBANS total score ≤ 80 9. MMSE score of greater than or equal to 24 10. Good physical health determined by physical examination, laboratory tests 11. Capacity and willingness to give written informed consent Exclusion Criteria: 1. Inability to read or speak English 2. Documented disease of the central nervous system 3. History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation) 4. Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions 5. HIV + 6. Patients diagnosed with substance dependence 7. Currently participating in another experimental study, except for the parent study.

Additional Information

Official title COMT Genotype and Response to Cognitive Remediation in Schizophrenia
Principal investigator Jean-Pierre Lindenmayer, M.D.
Description Cognitive deficits play a crucial role in both the pathogenesis and prognosis of schizophrenia. The COMT gene is functionally expressed in neural systems considered important in a range of healthy brain functions and brain disorders, including schizophrenia. The COMT Met allele has been shown to be associated with a lower activity form of COMT, and with better performance on neurocognitive tests, while the COMT Val allele is associated with poorer executive cognition. This study will investigate the relationship of COMT polymorphism in patients with chronic schizophrenia with the response to CRT targeting visuospatial processing, attention, and cognitive flexibility using MATRICS Consensus Cognitive Battery (MCCB) developed by the NIH-MATRICS initiative.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Manhattan Psychiatric Center.