We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664274
First Posted: April 22, 2008
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine, Inc.
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: COMT Genotype and Response to Cognitive Remediation in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Jean-Pierre Lindenmayer, 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 ]

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 ]
  • 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 ]
  • To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia. [ Time Frame: 12 weeks ]

Estimated Enrollment: 142
Study Start Date: April 2007
Estimated Study Completion Date: October 2016
Primary Completion Date: January 2015 (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.
Other Name: 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664274


Locations
United States, New York
Manhattan Psychiatric Center
Wards Island, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, M.D. Manhattan Psychiatric Center
Study Chair: Herbert Lachman, M.D. Albert Einstein College of Medicine, Inc.
Study Chair: Susan Mc Gurk, PhD New Hampshire-Dartmouth Psychiatric Research Center
Study Chair: Anzalee Khan, PhD Manhattan Psychiatric Center
  More Information

Additional Information:
Publications:
Responsible Party: Jean-Pierre Lindenmayer, Clinical Director, Manhattan Psychiatric Center
ClinicalTrials.gov Identifier: NCT00664274     History of Changes
Other Study ID Numbers: 061/C39-0
1R03MH078098-01 ( U.S. NIH Grant/Contract )
MRPC 2917 ( Other Grant/Funding Number: NIMH )
First Submitted: January 10, 2008
First Posted: April 22, 2008
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders