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

April 16, 2015 updated by: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

COMT Genotype and Response to Cognitive Remediation in Schizophrenia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Wards Island, New York, United States, 10035
        • Manhattan Psychiatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CRT Group
Behavioral: Cognitive remediation therapy
36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.
Other Names:
  • educational and behavioral training techniques
Genetic: COMT Genotyping
One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.
Other Names:
  • COMT polymorphism
  • 22q11.21-q11.23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Psychiatric Center

Collaborators

National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine

Investigators

  • Principal Investigator: Jean-Pierre Lindenmayer, M.D., Manhattan Psychiatric Center
  • Study Chair: Herbert Lachman, M.D., Albert Einstein College Of Medicine
  • Study Chair: Susan Mc Gurk, PhD, New Hampshire-Dartmouth Psychiatric Research Center
  • Study Chair: Anzalee Khan, PhD, Manhattan Psychiatric Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (ESTIMATE)

April 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061/C39-0
  • 1R03MH078098-01 (NIH)
  • MRPC 2917 (OTHER_GRANT: NIMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Schizophrenia

Clinical Trials on Cognitive remediation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe