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Clinical Trials/NCT01607424
NCT01607424
Completed
Not Applicable

Specific Versus General Cognitive Remediation for Schizophrenia

Hôpital le Vinatier0 sites151 target enrollmentDecember 2008
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Hôpital le Vinatier
Enrollment
151
Primary Endpoint
Change from baseline in executive functioning at week 12
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Rationale:

Cognitive deficits are a core feature in schizophrenia. Conventional treatments (antipsychotic medication and psychological treatments) have limited effects so cognitive remediation programs were designed to alleviate the problems. Interventions typically involve a variety of exercises in a paper and pencil or a computerized format with a growing number of specialized computer programs now being developed. However, many of these programs lack specificity which does not allow an individual's specific needs to be addressed. More targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation for Schizophrenia - was developed to fit this gap.

Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45 years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an already validated program (CRT).

220 patients will be randomized as follows :

  • Arm 1 : RECOS (42 h)
  • Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris, Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.
Registry
clinicaltrials.gov
Start Date
December 2008
End Date
October 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Principal Investigator
Principal Investigator

Nicolas FRANCK, Pr

Professor (Claude Bernard University), head of department (Hôpital le Vinatier), principal investigator

Hôpital le Vinatier

Eligibility Criteria

Inclusion Criteria

  • men and women aged 18 to 45 years
  • French speaker or French schooling since 7 years
  • clinical stability
  • diagnosis of schizophrenia

Exclusion Criteria

  • visual or auditory disorder
  • history of neurological illness or trauma
  • alcohol or drug dependence
  • mental retardation

Outcomes

Primary Outcomes

Change from baseline in executive functioning at week 12

Time Frame: week 12

BADS(Behavioral Assessement of Dysexecutive Functions) total score

Secondary Outcomes

  • Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12(week 12)
  • Change from baseline in insight at week 12(week 12)
  • Change from baseline in symptoms at week 12(week 12)
  • Change from baseline in self-esteem at week 12(week 12)

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