Back to resultsRelation of Catechol-O-methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia (COMT)
Primary Purpose
Chronic Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive remediation therapy
COMT Genotyping
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Participation in the active arm of the neurocognitive remediation program
- Age 18 - 55
- Inpatients
- DSM-IV diagnosis of schizophrenia (all subtypes) with illness duration >5 years
- Auditory and visual acuity adequate to complete cognitive tests
- Stable dose of oral atypical antipsychotic for at least 4 weeks
- Total PANSS score > 60
- RBANS total score ≤ 80
- MMSE score of greater than or equal to 24
- Good physical health determined by physical examination, laboratory tests
- Capacity and willingness to give written informed consent
Exclusion Criteria:
- Inability to read or speak English
- Documented disease of the central nervous system
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions
- HIV +
- Patients diagnosed with substance dependence
- Currently participating in another experimental study, except for the parent study.
Sites / Locations
- Manhattan Psychiatric Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CRT Group
Arm Description
Outcomes
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.
Secondary Outcome Measures
To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.
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.
To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
Full Information
NCT ID
NCT00664274
First Posted
January 10, 2008
Last Updated
April 16, 2015
Sponsor
Manhattan Psychiatric Center
Collaborators
National Institute of Mental Health (NIMH), Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00664274
Brief Title
Relation of Catechol-O-methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia
Acronym
COMT
Official Title
COMT Genotype and Response to Cognitive Remediation in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Psychiatric Center
Collaborators
National Institute of Mental Health (NIMH), Albert Einstein College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRT Group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation therapy
Other Intervention Name(s)
educational and behavioral training techniques
Intervention Description
36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.
Intervention Type
Genetic
Intervention Name(s)
COMT Genotyping
Other Intervention Name(s)
COMT polymorphism, 22q11.21-q11.23
Intervention Description
One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the active arm of the neurocognitive remediation program
Age 18 - 55
Inpatients
DSM-IV diagnosis of schizophrenia (all subtypes) with illness duration >5 years
Auditory and visual acuity adequate to complete cognitive tests
Stable dose of oral atypical antipsychotic for at least 4 weeks
Total PANSS score > 60
RBANS total score ≤ 80
MMSE score of greater than or equal to 24
Good physical health determined by physical examination, laboratory tests
Capacity and willingness to give written informed consent
Exclusion Criteria:
Inability to read or speak English
Documented disease of the central nervous system
History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions
HIV +
Patients diagnosed with substance dependence
Currently participating in another experimental study, except for the parent study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Lindenmayer, M.D.
Organizational Affiliation
Manhattan Psychiatric Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert Lachman, M.D.
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan Mc Gurk, PhD
Organizational Affiliation
New Hampshire-Dartmouth Psychiatric Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anzalee Khan, PhD
Organizational Affiliation
Manhattan Psychiatric Center
Official's Role
Study Chair
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
Wards Island
State/Province
New York
ZIP/Postal Code
10035
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17123785
Citation
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.
Results Reference
background
PubMed Identifier
17383818
Citation
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.
Results Reference
background
Links:
URL
http://www.nimh.nih.gov/science-news/2005/brain-scans-reveal-how-gene-may-boost-schizophrenia-risk.shtml
Description
NIMH Press: Brain Scans Reveal How Gene May Boost Schizophrenia Risk
URL
http://en.wikipedia.org/wiki/COMT
Description
Wikipedia: Catechol-O-methyl transferase
Learn more about this trial
Relation of Catechol-O-methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia
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