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Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training (fMRI)

This study has been completed.
Sponsor:
Collaborator:
Nathan Kline Institute for Psychiatric Research
Information provided by:
Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00431223
First received: February 2, 2007
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Schizophrenia
Behavioral: Cognitive remediation therapy
Other: No Computerized Cognitive Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia?

Resource links provided by NLM:


Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:
  • Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: September 2006
Study Completion Date: September 2008
Arms Assigned Interventions
Active Comparator: Active Group Behavioral: Cognitive remediation therapy
36 sessions of computerized cognitive skills training over a 12 week duration.
Other Name: CRT
No Intervention: Control Group Other: No Computerized Cognitive Skills Training
Patients attend 'treatment-as-usual' mall program sessions, with similar clinician exposure time as the active group.

Detailed Description:

Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.

After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.

Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.

Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.

All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 hematological conditions; HIV positive
  • Any medical condition rendering the subject unable to receive an fMRI scan
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431223

Locations
United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
Nathan Kline Institute for Psychiatric Research
Investigators
Principal Investigator: Saurabh Kaushik, MD Manhattan Psychaitric Center
Study Chair: 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
  More Information

Additional Information:
Publications:
Responsible Party: Saurabh Kaushik, Manhattan Psychiatric Center
ClinicalTrials.gov Identifier: NCT00431223     History of Changes
Other Study ID Numbers: 05I/C52
Study First Received: February 2, 2007
Last Updated: August 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Manhattan Psychiatric Center:
fMRI
working memory
schizophrenia
treatment refractory
cognitive skills training
dorsolateral prefrontal cortex
cognitive remediation
treatment refractory schizophrenia of > 5 years duration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014