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

NCT ID: NCT00664274

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CRT Group

Group Type OTHER

Cognitive remediation therapy

Intervention Type BEHAVIORAL

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

COMT Genotyping

Intervention Type GENETIC

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

Interventions

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Cognitive remediation therapy

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

Intervention Type BEHAVIORAL

COMT Genotyping

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

Intervention Type GENETIC

Other Intervention Names

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educational and behavioral training techniques COMT polymorphism 22q11.21-q11.23

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Manhattan Psychiatric Center

OTHER

Sponsor Role lead

Responsible Party

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Jean-Pierre Lindenmayer

Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Pierre Lindenmayer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Manhattan Psychiatric Center

Herbert Lachman, M.D.

Role: STUDY_CHAIR

Albert Einstein College of Medicine

Susan Mc Gurk, PhD

Role: STUDY_CHAIR

New Hampshire-Dartmouth Psychiatric Research Center

Anzalee Khan, PhD

Role: STUDY_CHAIR

Manhattan Psychiatric Center

Locations

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Manhattan Psychiatric Center

Wards Island, New York, United States

Site Status

Countries

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United States

References

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Woodward ND, Jayathilake K, Meltzer HY. COMT val108/158met genotype, cognitive function, and cognitive improvement with clozapine in schizophrenia. Schizophr Res. 2007 Feb;90(1-3):86-96. doi: 10.1016/j.schres.2006.10.002. Epub 2006 Nov 22.

Reference Type BACKGROUND
PMID: 17123785 (View on PubMed)

Bosia M, Bechi M, Marino E, Anselmetti S, Poletti S, Cocchi F, Smeraldi E, Cavallaro R. Influence of catechol-O-methyltransferase Val158Met polymorphism on neuropsychological and functional outcomes of classical rehabilitation and cognitive remediation in schizophrenia. Neurosci Lett. 2007 May 7;417(3):271-4. doi: 10.1016/j.neulet.2007.02.076. Epub 2007 Mar 2.

Reference Type BACKGROUND
PMID: 17383818 (View on PubMed)

Related Links

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http://en.wikipedia.org/wiki/COMT

Wikipedia: Catechol-O-methyl transferase

Other Identifiers

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1R03MH078098-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MRPC 2917

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

061/C39-0

Identifier Type: -

Identifier Source: org_study_id

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