Clinical trial NCT01607424: Specific Cognitive Remediation for Schizophrenia
Official title: Specific Versus General Cognitive Remediation for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: cognitive rehabilitation
schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Centre hospitalier Saint Jean de Dieu - ARHM
name: Saint Anne's Hospital
First posted: 2012-05-30
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in executive functioning at week 12
timeFrame: week 12
Secondary outcomes:
measure: Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
timeFrame: week 12
measure: Change from baseline in symptoms at week 12
timeFrame: week 12
measure: Change from baseline in self-esteem at week 12
timeFrame: week 12
measure: Change from baseline in insight at week 12
timeFrame: week 12
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital le Vinatier
name: Nicolas Franck
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network; Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.