Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels
This trial is active, not recruiting.
|Treatments||cognitive remediation therapy, psychoeducation|
|Sponsor||Hospital Clinic of Barcelona|
|Collaborator||University of Barcelona|
|Start date||January 2012|
|End date||December 2015|
|Trial size||70 participants|
|Trial identifier||NCT02341131, PI 11/01958|
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.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
BDNF (change from baseline serum BDNF levels)
time frame: Baseline, 1 month and 4 months
Symptoms (Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores)
time frame: Baseline and 4 months
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1. - Presence of cognitive deficit confirmed by the neuropsychological battery - Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment. Exclusion Criteria: - Presence of organic-cerebral affectation due to neurological or traumatic conditions - Abuse of psychotropic substances - Presence of other psychiatric symptomatology
|Official title||BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia|
|Principal investigator||Rafael Penadés, Ph.D.|
|Description||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.|
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