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Completed

NCT Number: NCT01078129

Cognitive Remediation Therapy and Schizophrenia

Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Cognition Disorders Mental Disorders Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital le vinatier

Bron, 69677, France

About this study

Methods:

In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • schizophrenia (DSM IV criteria)
  • remitted symptoms
  • french language
  • informed consent

Exclusion criteria

  • addiction, neurological disease
  • only for second randomized patient participating in MRI study (n=30) : MRI counterindications

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software

Other names: CRT, behavioral intervention

non-CRT

Behavioral

waiting list

Other names: no intervention

Primary outcomes

  1. cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)

    Time frame: before and after CRT (3 months later)

    standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).

Secondary outcomes

  1. brain functioning (fMRI)

    Time frame: before and after CRT (3 months later)

    fMRI during a n-back task, 2 times, before CRT and 3 months later. The 2 sub-groups of 15 patients will be compared with healthy subjects performances at the same task.

  2. schizophrenia symptoms

    Time frame: before CRT and 3 months later

    standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Collaborators

  • University Hospital, Clermont-Ferrand
  • University Hospital, Grenoble

Registry information

Official study title

Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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