Relation of Catechol-O-methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia

Not Applicable

• Conditions: Chronic Schizophrenia
• Interventions: Behavioral: Cognitive remediation therapy; Genetic: COMT Genotyping

• Registration Number: NCT00664274
• Lead Sponsor: Manhattan Psychiatric Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Primary Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT Group	Cognitive remediation therapy	-
CRT Group	COMT Genotyping	-

Primary Outcome Measures

Name	Time	Method
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.	12 weeks

Secondary Outcome Measures

Name	Time	Method
To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.	12 weeks
To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.	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.	12 weeks

Trial Locations

Locations (1)

Manhattan Psychiatric Center; 🇺🇸 Wards Island, New York, United States