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Report for Clinical Trial NCT02341131

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02341131 Schizophrenia
MeSH:Schizophrenia
HPO:Schizophrenia

2 Interventions

Name: Cognitive Remediation Therapy

Description: The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.
Type: Behavioral
Group Labels: 1

Cognitive Remediation Therapy

Name: Psychoeducation

Description: The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.
Type: Behavioral
Group Labels: 1

Psychoeducation


Primary Outcomes

Description: Change Measurements of serum BDNF levels will be carried out by personnel blind to subjects' group assignment. Platelet and serum samples will be diluted with diluent included in the R&D Human BDNF Quantikine Enzym Linked Immunosorbent Assay (ELISA) kit (Yasuhito et al. 1987).

Measure: BDNF (change from baseline serum BDNF levels)

Time: Baseline, 1 month and 4 months

Secondary Outcomes

Description: Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks

Measure: Symptoms (Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores)

Time: Baseline and 4 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

Additionally, the role as outcome predictors of BDNF serum levels and the Val66met polymorphism and data from functional and structural neuroimaging will be studied. --- Val66met ---



HPO Nodes


HPO: