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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01279070 |
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Date of registration:
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14/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
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Scientific title:
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Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia. |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01279070 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Aida Farreny, PhD Psycho. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació Sant Joan de Déu |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of schizophrenia or schizoaffective disorder
- More than 2 years illness duration
- Literate
- Mini Mental Status Examination score over 24
- Global Assessment of Functioning scores between 40 and 70
Exclusion Criteria:
- Current acute illness exacerbation
- Mental Retardation
- Neurological disorder which impairs cognition
- Currently participating in social skills training or cognitive remediation
- Change of antipsychotic medication one month before the trial or during the 40 study
weeks
- Diagnosis of alcohol or drug dependence within 6 months of trial commencement.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Indication for Modification of Patient Cognitive Status
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Intervention(s)
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Behavioral: Repyflec cognitive remediation training
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Primary Outcome(s)
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Executive Function
[Time Frame: Change from baseline in executive function at 16 weeks (post-treatment)]
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Executive Function
[Time Frame: Change from baseline in executive functioning at 40 weeks]
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Secondary Outcome(s)
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Psychosocial Functioning
[Time Frame: Change from baseline in social functioning scales at 40 weeks]
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Psychosocial Functioning
[Time Frame: Change from baseline in social functioning scales at 16 weeks]
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Psychiatric Symptoms
[Time Frame: Change from baseline in psychiatric symptoms scales at 40 weeks]
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Psychiatric Symptoms
[Time Frame: Change from baseline in psychiatric symptoms scales at 16 weeks]
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Secondary ID(s)
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REPYFLEC Clinical Trial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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