Specific Cognitive Remediation for Schizophrenia

Schizophrenia Clinical Trial

— RECOS  

Official title:

Specific Versus General Cognitive Remediation for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607424
• Other study ID #: RECOS
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: September 2, 2015
• Start date: December 2008
• Est. completion date: October 2011

Study information

• Verified date: September 2015
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• cognitive remediation
RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hôpital le Vinatier	Centre hospitalier Saint Jean de Dieu - ARHM, Saint Anne's Hospital

References & Publications (1)

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; Members of Cognitive Remediation Network, Viani — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in executive functioning at week 12	BADS(Behavioral Assessement of Dysexecutive Functions) total score	week 12	No
Secondary	Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12	comprehensive neuropsychological assessment	week 12	No
Secondary	Change from baseline in symptoms at week 12	PANSS (Positive And Negative Symptoms Scale)	week 12	No
Secondary	Change from baseline in self-esteem at week 12	Rosenberg scale	week 12	No
Secondary	Change from baseline in insight at week 12	Birchwood scale	week 12	No