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OpenTrials
Completed

NCT Number: NCT01607424

Specific Cognitive Remediation for Schizophrenia

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cognitive Remediation

Behavioral

RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy

Primary outcomes

  1. Change from baseline in executive functioning at week 12

    Time frame: week 12

    BADS(Behavioral Assessement of Dysexecutive Functions) total score

Secondary outcomes

  1. Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12

    Time frame: week 12

    comprehensive neuropsychological assessment

  2. Change from baseline in symptoms at week 12

    Time frame: week 12

    PANSS (Positive And Negative Symptoms Scale)

  3. Change from baseline in self-esteem at week 12

    Time frame: week 12

    Rosenberg scale

  4. Change from baseline in insight at week 12

    Time frame: week 12

    Birchwood scale

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Collaborators

  • Centre hospitalier Saint Jean de Dieu - ARHM
  • Saint Anne's Hospital

Registry information

Official study title

Specific Versus General Cognitive Remediation for Schizophrenia

Acronym: RECOS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 30, 2012
Registry last updated
Sep 3, 2015

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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