Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

Not Applicable

• Conditions: Schizophrenia
• Interventions: Behavioral: Cognitive Remediation Therapy

• Registration Number: NCT04278027
• Lead Sponsor: Hospital Clinic of Barcelona

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 Timeline

• Study Start: 2017-01-03
• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-05-05
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of schizophrenia according to DSM-5 and confirmed by the semi-structured interview (SCID) for the axis 1.
• Presence of cognitive impairment 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
• Antipsychotic dose change >10%
• Abuse of psychotropic substances
• Presence of other psychiatric symptomatology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation Therapy	Cognitive Remediation Therapy	Cognitive Remediation Therapy. CRT will be based on CIRCuiTS, a computerized program.

Primary Outcome Measures

Name	Time	Method
Change in methylation at Cytosine-phosphate-Guanine (CpG) exon	Baseline and after 4 months	Mean methylation percentage in CpG island BDNF CpG exon I: located at chr11:27743473-27744564 in the BDNF
Change in methylation at CpG exon IV	Baseline and after 4 months	Mean methylation percentage of CpG region BDNF CpG exon IV: located at chr11:27723060-27723294 in exon IV, upstream of the start codon in exon VII

Secondary Outcome Measures

Name	Time	Method
Change in cognition	Baseline and after 4 months	Total score in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Change in Symptoms	Baseline and after 4 months	Total score in Positive and Negative Syndromes Scale (PANSS)

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain