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

Manhattan Psychiatric Center

Status: Unknown

Conditions: Chronic Schizophrenia

Treatments: Behavioral: Cognitive remediation therapy; Genetic: COMT Genotyping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00664274

MRPC 2917 (Other Grant/Funding Number)

061/C39-0

1R03MH078098-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 1 patient group

CRT Group

Other group

Treatment:

Genetic: COMT Genotyping

Behavioral: Cognitive remediation therapy