SchizophreniaRECOSNCT01607424
Specific Cognitive Remediation for Schizophrenia
A study testing cognitive remediation in people with Schizophrenia, run by Hôpital le Vinatier.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women aged 18 to 45 years
- French speaker or French schooling since 7 years
- clinical stability
- diagnosis of schizophrenia
Who cannot join
- visual or auditory disorder
- history of neurological illness or trauma
- alcohol or drug dependence
- mental retardation
About this study
Official title: Specific Versus General 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.
Read more
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.
- Conditions
- Schizophrenia
- Being tested
- cognitive remediation
- Keywords
- cognitive rehabilitation, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive remediationBehavioural
RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
| Study group | Role | What they receive |
|---|---|---|
| RECOS: 42 hours CR, 14 week-treatment. | Experimental | RECOS(Cognitive Remediation for Schizophrenia) exercises were designed by SBT Company and adapted by Vianin et al (2007) for specific use in schizophrenia. It includes computer based and paper and pencil exercises that target 5 main cognitive functions. RECOS modules focus on the relevant cognitive domains, which have been recommended by the MATRICS consensus. Each exercise has 10 difficulty levels. Allocation of the training modules in RECOS was determined according to the standard scores obtained in the comprehensive neuropsychological assessment. Each patient participated in the module corresponding to his/her most altered cognitive area. Receives: Behavioral: cognitive remediation |
| CRT: 42 hours CR, 14 week-treatment | Active comparator | CRT (Cognitive Remediation Therapy) exercises are the ones used by Wykes et al (1999). The CRT method consists of 3 modules: flexibility, memory (A and B) and planning (A and B). Each module involves a series of paper and pencil exercises with parallel forms providing with gradual difficulty. Receives: Behavioral: cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in executive functioning at week 12
BADS(Behavioral Assessement of Dysexecutive Functions) total score
Measured: week 12
Secondary outcomes (4)
Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
comprehensive neuropsychological assessment
Measured: week 12
Change from baseline in symptoms at week 12
PANSS (Positive And Negative Symptoms Scale)
Measured: week 12
Change from baseline in self-esteem at week 12
Rosenberg scale
Measured: week 12
Change from baseline in insight at week 12
Birchwood scale
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier Saint Jean de Dieu - ARHM, Saint Anne's Hospital
- Responsible party
- Principal investigator, Nicolas FRANCK, Pr, Hôpital le Vinatier
- Investigators
- Nicolas Franck, Principal investigator, Hôpital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607424
- Sponsor's protocol ID
- RECOS
- Acronym
- RECOS
- Status last verified
- Sep 2015
- First submitted
- 11 May 2012
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23583327
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Versus General Cognitive Remediation for Schizophrenia
- ClinicalTrials.gov ID
- NCT01607424
- Acronym / sponsor ID
- RECOS / RECOS
- Conditions
- Schizophrenia
- Keywords
- cognitive rehabilitation, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- Centre hospitalier Saint Jean de Dieu - ARHM, Saint Anne's Hospital
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECOS: 42 hours CR, 14 week-treatment. | Experimental | Behavioral: cognitive remediationRECOS(Cognitive Remediation for Schizophrenia) exercises were designed by SBT Company and adapted by Vianin et al (2007) for specific use in schizophrenia. It includes computer based and paper and pencil exercises that target 5 main cognitive functions. RECOS modules focus on the relevant cognitive domains, which have been recommended by the MATRICS consensus. Each exercise has 10 difficulty levels. Allocation of the training modules in RECOS was determined according to the standard scores obtained in the comprehensive neuropsychological assessment. Each patient participated in the module corresponding to his/her most altered cognitive area. |
| CRT: 42 hours CR, 14 week-treatment | Active comparator | Behavioral: cognitive remediationCRT (Cognitive Remediation Therapy) exercises are the ones used by Wykes et al (1999). The CRT method consists of 3 modules: flexibility, memory (A and B) and planning (A and B). Each module involves a series of paper and pencil exercises with parallel forms providing with gradual difficulty. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- men and women aged 18 to 45 years
- French speaker or French schooling since 7 years
- clinical stability
- diagnosis of schizophrenia
Key exclusion criteria (4 listed)
- visual or auditory disorder
- history of neurological illness or trauma
- alcohol or drug dependence
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive remediationRECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy | Behavioural | CRT: 42 hours CR, 14 week-treatment, RECOS: 42 hours CR, 14 week-treatment. |
Primary outcome
Change from baseline in executive functioning at week 12
Time frame: week 12
BADS(Behavioral Assessement of Dysexecutive Functions) total score
4 secondary outcomes
Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
Time frame: week 12
Change from baseline in symptoms at week 12
Time frame: week 12
Change from baseline in self-esteem at week 12
Time frame: week 12
Change from baseline in insight at week 12
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Results publication: PubMed 23583327Franck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Franck principal investigator
Hôpital le Vinatier
Questions about this trial
What is this clinical trial studying?
A study testing cognitive remediation in people with Schizophrenia, run by Hôpital le Vinatier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in executive functioning at week 12 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015; AzTrials last refreshed its copy on 31 Oct 2026.