Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

Schizophrenia Clinical Trial

Official title:

Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04278027
• Other study ID #: 24618
• Secondary ID: PI17/00872
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: June 15, 2020

Study information

• Verified date: February 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Cognitive Remediation Therapy
"CIRCuiTS is a web-based computerised CR therapy, delivered by a therapist but supplemented with independent sessions to facilitate massed practice. It targets metacognition, particularly strategy use, in addition to providing massed practice of basic cognitive functions. The therapist facilitates motivation, metacognitive and strategy development and generalisation of learning by encouraging the participant to learn about and regulate their cognitive performance and to transfer this learning to meet real-world goals. Therapists provide additional scaffolding for CR tasks to ensure consistent successful performance. Independent sessions involve carrying out cognitive tasks allocated by the therapist to ensure scaffolded learning" (Reeder et al.2017)

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Instituto de Salud Carlos III, National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in methylation at Cytosine-phosphate-Guanine (CpG) exon	Mean methylation percentage in CpG island BDNF CpG exon I: located at chr11:27743473-27744564 in the BDNF	Baseline and after 4 months
Primary	Change in methylation at CpG exon IV	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	Baseline and after 4 months
Secondary	Change in cognition	Total score in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	Baseline and after 4 months
Secondary	Change in Symptoms	Total score in Positive and Negative Syndromes Scale (PANSS)	Baseline and after 4 months