SchizophreniaNCT01078129
Cognitive Remediation Therapy and Schizophrenia
A study testing cognitive remediation therapy and non-CRT in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- cognitive remediation therapy and non-CRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Dec 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- schizophrenia (DSM IV criteria)
- remitted symptoms
- french language
- informed consent
Who cannot join
- addiction, neurological disease
- only for second randomized patient participating in MRI study (n=30) : MRI counterindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia
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.
Read the detailed 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).
- Conditions
- Schizophrenia
- Being tested
- cognitive remediation therapy, non-CRT
- Keywords
- cognitive deficits
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive remediation therapyBehavioural
Also called CRT, behavioral intervention
program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software
non-CRTBehavioural
Also called no intervention
waiting list
| Study group | Role | What they receive |
|---|---|---|
| behavior therapy - CRT | Active comparator | behavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software Receives: Behavioral: cognitive remediation therapy |
| non-CRT | Sham comparator | no intervention Receives: Behavioral: non-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before and after CRT (3 months later)
Secondary outcomes (2)
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.
Measured: before and after CRT (3 months later)
schizophrenia symptoms
standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)
Measured: before CRT and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionDec 2010
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Thierry d'amato, MD, PhD, Principal investigator, Hopital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078129
- Sponsor's protocol ID
- 2005-094B
- Status last verified
- Feb 2014
- First submitted
- 22 Feb 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2.
PubMed 21543191
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia
- ClinicalTrials.gov ID
- NCT01078129
- Acronym / sponsor ID
- 2005-094B
- Conditions
- Schizophrenia
- Keywords
- cognitive deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, University Hospital, Clermont-Ferrand
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Mar 2010 (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.
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.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavior therapy - CRT | Active comparator | Behavioral: cognitive remediation therapybehavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software |
| non-CRT | Sham comparator | Behavioral: non-CRTno intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- schizophrenia (DSM IV criteria)
- remitted symptoms
- french language
- informed consent
Key exclusion criteria (2 listed)
- addiction, neurological disease
- only for second randomized patient participating in MRI study (n=30) : MRI counterindications
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 remediation therapyAlso: CRT, behavioral interventionprogram consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software | Behavioural | behavior therapy - CRT |
| non-CRTAlso: no interventionwaiting list | Behavioural | non-CRT |
Primary outcome
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)
Time frame: before and after CRT (3 months later)
standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).
2 secondary outcomes
brain functioning (fMRI)
Time frame: before and after CRT (3 months later)
schizophrenia symptoms
Time frame: before CRT and 3 months later
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 25 Feb 2014.
- Derived from this study: PubMed 21543191Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2.
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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.
Thierry d'amato, MD, PhD principal investigator
Hopital le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive remediation therapy and non-CRT in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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 2 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions) (time frame: before and after CRT (3 months later)). 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 NCT01078129, 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 25 Feb 2014.