- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619319
Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:1.
- Male or female between 12 and 35 years old.
- Understand and sign an informed consent (or assent for minors) document in English.
- Must meet the NAPLS substance use criteria (see guidelines).
Meet diagnostic criteria for prodromal syndrome as per COPS Criteria (see below) or if under 19 meet criteria for schizotypal personality disorder.
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Exclusion Criteria:
- Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
- No current treatment with antipsychotic medication unless it can be clearly demonstrated that the diagnostic prodromal criteria were present prior to the antipsychotic.
- Impaired intellectual functioning (i.e IQ<70); however those with an IQ in the 65-69 range will be included if the WRAT reading >75.
- Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
- Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.
The diagnostic prodromal symptoms are clearly caused by an Axis 1 disorder, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic DSM-IV disorders will not be exclusionary (e.g. substance abuse disorder, major depression, anxiety disorders, Axis II Disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Remediation Therapy
A computerised cognitive remediation intervention called the Brain Fitness program is compared against a placebo intervention consisting of computer games
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auditory computer games designed to improve the speed at which people react when they hear something and at which they process that information.
Other Names:
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Active Comparator: computer games
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computer games that that consist of word puzzles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Time Frame: 12 months
|
MATRICS will be used to assess changes in cognition at the end of treatment and 12 months post baseline.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GFS= Global Functioning Scale (GFS): Social and Role
Time Frame: 12 months
|
Functioning scales will be used to asses if changes in cognitive function are associated with changes in social and role functioning.
|
12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Addington, PhD, University of Calgary
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cognitive Remediation in CHR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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