Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Schizophrenia

Treatments: Behavioral: Cognitive Remediation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04278027

24618

PI17/00872 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Cognitive Remediation Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Remediation Therapy

Treatment as usual

No Intervention group

Description:

Treatment as usual