NCT00664274

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

7.8 years

First QC Date

January 10, 2008

Last Update Submit

April 16, 2015

Conditions

Chronic Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.

    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.

    12 weeks

  • To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.

    12 weeks

Study Arms (1)

CRT Group

OTHER
Behavioral: Cognitive remediation therapyGenetic: COMT Genotyping

Interventions

Cognitive remediation therapyBEHAVIORAL

36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.

Also known as: educational and behavioral training techniques
CRT Group
COMT GenotypingGENETIC

One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.

Also known as: COMT polymorphism, 22q11.21-q11.23
CRT Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Psychiatric Center

Wards Island, New York, 10035, United States

Location

Related Publications (2)

  • 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.

    PMID: 17123785BACKGROUND

  • 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.

    PMID: 17383818BACKGROUND

Related Links

Study Officials

  • Jean-Pierre Lindenmayer, M.D.

    Manhattan Psychiatric Center

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

January 10, 2008

First Posted

April 22, 2008

Study Start

April 1, 2007

Primary Completion

January 1, 2015

Study Completion

October 1, 2016

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)