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Relation of Catechol-O-Methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia
This study is currently recruiting participants.
Verified by Manhattan Psychiatric Center, April 2008
First Received: January 10, 2008   Last Updated: April 21, 2008   History of Changes
Sponsors and Collaborators: Manhattan Psychiatric Center
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine of Yeshiva University
Information provided by: Manhattan Psychiatric Center
ClinicalTrials.gov Identifier: NCT00664274
  Purpose

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.


Condition Intervention
Chronic Schizophrenia
 Behavioral: Cognitive remediation therapy
Genetic: COMT Genotyping

MedlinePlus related topics: Rehabilitation Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Open Label, Single Group Assignment
Official Title: COMT Genotype and Response to Cognitive Remediation in Schizophrenia

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CRT Group Behavioral: Cognitive remediation therapy
36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.
Genetic: COMT Genotyping
One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664274

Contacts
Contact: Saurabh Kaushik, M.D. 646-672-6352 maisskk@Omh.state.ny.us
Contact: Sashank Kaushik, M.D. 646-672-6177 marcskk@Omh.state.ny.us

Locations
United States, New York
Manhattan Psychiatric Center Recruiting
Wards Island, New York, United States, 10035
Contact: Anzalee Khan, PhD Candidate         marcakk@omh.state.ny.us    
Contact: Sashank Kaushik, M.D.         marcskk@omh.state.ny.us    
Sub-Investigator: Adel Iskander, M.D.            
Sponsors and Collaborators
Manhattan Psychiatric Center
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, M.D. Manhattan Psychiatric Center
Study Chair: Saurabh Kaushik, M.D. Manhattan Psychiatric Center
Study Chair: Herbert Lachman, M.D. Albert Einstein College of Medicine of Yeshiva University
Study Chair: Susan Mc Gurk, PhD New Hampshire-Dartmouth Psychiatric Research Center
Study Chair: Anzalee Khan, PhD Candidate Manhattan Psychiatric Center
  More Information

Additional Information:
NIMH Press: Brain Scans Reveal How Gene May Boost Schizophrenia Risk  This link exits the ClinicalTrials.gov site
NIMH News Release: Gene Slows Frontal Lobes, Boosts Schizophrenia Risk  This link exits the ClinicalTrials.gov site
NIH Videocast: "Complex Genetics in the Human Brain: Lessons from COMT"  This link exits the ClinicalTrials.gov site
Wikipedia: Catechol-O-methyl transferase  This link exits the ClinicalTrials.gov site
COMT on National Library of Medicine  This link exits the ClinicalTrials.gov site

Publications:
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. Epub 2006 Nov 22.
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. Epub 2007 Mar 2.

Responsible Party: Manhattan Psychiatric Center ( Jean Pierre Lindenmayer, MC )
Study ID Numbers: 061/C39-0, 1R03MH078098-01
Study First Received: January 10, 2008
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00664274     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009



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