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

Chronic Schizophrenia Clinical Trial

— COMT  

Official title:

COMT Genotype and Response to Cognitive Remediation in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00664274
• Other study ID #: 061/C39-0
• Secondary ID: 1R03MH078098-01M
• Status: Active, not recruiting
• Phase: N/A
• First received: January 10, 2008
• Last updated: April 16, 2015
• Start date: April 2007
• Est. completion date: October 2016

Study information

• Verified date: April 2015
• Source: Manhattan Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: October 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	Wards Island	New York

Sponsors (3)

Lead Sponsor	Collaborator
Manhattan Psychiatric Center	Albert Einstein College of Medicine of Yeshiva University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2006 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	No
Secondary	To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.		12 weeks	No
Secondary	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.		12 weeks	No
Secondary	To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.		12 weeks	No

External Links

•   COMT on National Library of Medicine
•   NIMH Press: Brain Scans Reveal How Gene May Boost Schizophrenia Risk
•   Wikipedia: Catechol-O-methyl transferase