Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02341131
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2015-01-08
Brief Title:
Cognitive Remediation Therapy in Schizophrenia Effects on BDNF Levels
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None