Cognitive Remediation Therapy and Schizophrenia

Schizophrenia Clinical Trial

Official title:

Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078129
• Other study ID #: 2005-094B
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 24, 2014
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: February 2014
• 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)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• cognitive remediation therapy
program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software
• non-CRT
waiting list

Locations

Country	Name	City	State
France	Hôpital le vinatier	Bron

Sponsors (3)

Lead Sponsor	Collaborator
Hôpital le Vinatier	University Hospital, Clermont-Ferrand, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)	standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).	before and after CRT (3 months later)	No
Secondary	brain functioning (fMRI)	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.	before and after CRT (3 months later)	No
Secondary	schizophrenia symptoms	standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)	before CRT and 3 months later	No