NCT00431223

Brief Summary

This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

February 2, 2007

Last Update Submit

October 2, 2020

Conditions

Schizophrenia

Keywords

fMRIworking memoryschizophreniatreatment refractorycognitive skills trainingdorsolateral prefrontal cortexcognitive remediationtreatment refractory schizophrenia of > 5 years duration

Outcome Measures

Primary Outcomes (1)

  • Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC)

    12 weeks

Secondary Outcomes (1)

  • Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests

    12 weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR

7 patients were assigned to Cognitive Remediation Therapy..

Behavioral: Cognitive remediation therapy

Control Group

NO INTERVENTION

4 patients were assigned to Control group or no cognitive remediation therapy.

Interventions

Cognitive remediation therapyBEHAVIORAL

36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.

Also known as: CRT Group
Active Group

Eligibility Criteria

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

You may qualify if:

  • Inpatient status
  • Age 18 - 55
  • Male gender (females are enrolled but will not be scanned)
  • DSM-IV diagnosis of schizophrenia (all subtypes) and schizoaffective disorder
  • illness duration \> 5 years
  • MMSE score \> 24 (inclusive) at screening
  • Stable dose of oral atypical antipsychotic for at least 4 weeks prior to study entry
  • Total PANSS score \> 60 at screening
  • Capacity and willingness to give written informed consent
  • Patients deemed not ready to be discharged within the next 12 weeks

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 hematological conditions; HIV positive
  • Any medical condition rendering the subject unable to receive an fMRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Related Publications (1)

  • Wykes T, Reeder C, Corner J, Williams C, Everitt B. The effects of neurocognitive remediation on executive processing in patients with schizophrenia. Schizophr Bull. 1999;25(2):291-307. doi: 10.1093/oxfordjournals.schbul.a033379.

    PMID: 10416732BACKGROUND

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Saurabh Kaushik, MD

    Manhattan Psychaitric Center

    PRINCIPAL INVESTIGATOR

  • Jean-Pierre Lindenmayer, MD

    Manhattan Psychiatric Center

    STUDY CHAIR

  • Susan McGurk, PhD

    Dartmouth College, Hanover

    STUDY CHAIR

  • Craig A. Branch, PhD

    Center for Advanced Brain Imaging, NKI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

US(1)