Viewing Study NCT04278027



Ignite Creation Date: 2024-05-06 @ 2:17 PM
Last Modification Date: 2024-10-26 @ 1:28 PM
Study NCT ID: NCT04278027
Status: UNKNOWN
Last Update Posted: 2020-02-20
First Post: 2020-02-17

Brief Title: Cognitive Remediation Therapy in Schizophrenia Effects on Epigenetics
Sponsor: Hospital Clinic of Barcelona
Organization: Hospital Clinic of Barcelona

Study Overview

Official Title: Epigenetic Regulation of Brain-Derived Neurotrophic Factor BDNF Gene Expression According to Response to Cognitive Remediation in Schizophrenia
Status: UNKNOWN
Status Verified Date: 2020-02
Last Known Status: ACTIVE_NOT_RECRUITING
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: This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy CRT can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia
Detailed Description: OBJECTIVES To investigate whether Cognitive Remediation Therapy CRT can modulate epigenetic mechanisms by changing methylation levels of BDNF gene It also aims to test whether BDNF valine-66-methionine Val66Met polymorphism influences CRT treatment outcome among people with schizophrenia

SAMPLE AND METHODS A randomized and controlled study will be carried out with two groups patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual TAU Methylation levels of BDNF gene at different sites will be contrasted before and after treatment Additionally neurocognition profile level of symptoms and psychosocial functioning will also be tested CRT outcomes will be investigated in a mixed model for repeated measures

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
PI1700872 OTHER_GRANT Instituto de Salud Carlos III None