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

COMT Genotype and Response to Cognitive Remediation in Schizophrenia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00664274
Acronym
COMT
Enrollment
142
Registered
2008-04-22
Start date
2007-04-30
Completion date
2016-10-31
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Schizophrenia

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.

Interventions

BEHAVIORALCognitive remediation therapy

36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.

GENETICCOMT Genotyping

One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Albert Einstein College of Medicine
CollaboratorOTHER
Manhattan Psychiatric Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 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
To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026