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BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia
The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a putative biological marker of the cognitive recovery in schizophrenia following a Cognitive Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels and the Val66met polymorphism and data from functional and structural neuroimaging will be studied.
Forty patients with schizophrenia disorder and twenty healthy volunteers will be recruited. Patients will be randomly allocated either the experimental group, undergoing an individual CRT for 40 hours during 16 weeks, or the control group following a psycho-educational intervention without any neurocognitive work, both lasting the same amount of hours and period of time. Blood samples will be obtained from participants in four moments: before treatment, at week 4, at week 16, and at 32 week follow-up. In addition, repeated measurements will be obtained with a neurocognitive battery based on the MATRICS consensus battery and the Positive And Negative Syndromes Scale (PANSS). Assessments will be conducted by trained personnel who will remain blind to the group assignment. A factorial model will be performed conducting a repeated measures analysis of covariance (ANCOVA) to study the effects of CRT on the levels of BDNF, neurocognition, symptoms and social functioning, adding the necessary co-variants. Finally, a linear regression model to determine the predictive role of serum levels of BDNF and data from functional and structural neuroimaging on the effects of CRT will be performed.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Hospital Clínic Barcelona
Barcelona, Barcelona, Spain
Start Date
January 1, 2012
Primary Completion Date
December 1, 2015
Completion Date
March 1, 2016
Last Updated
February 17, 2017
70
ACTUAL participants
Cognitive Remediation Therapy
BEHAVIORAL
Psychoeducation
BEHAVIORAL
Lead Sponsor
Hospital Clinic of Barcelona
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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