Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

NCT04278027 | Unknown

• 2 other identifiers: 24618PI17/00872
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Cognitive Remediation; Epigenetics; BDNF

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in cognition

  Baseline and after 4 months

• Change in Symptoms

  Baseline and after 4 months

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Remediation Therapy

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

Cognitive Remediation Therapy BEHAVIORAL

"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)

Also known as: CIRCuiTS

Cognitive Remediation Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• Presence of organic-cerebral affectation due to neurological or traumatic conditions
• Antipsychotic dose change \>10%
• Abuse of psychotropic substances
• Presence of other psychiatric symptomatology

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• Penades R, Almodovar-Paya C, Garcia-Rizo C, Ruiz V, Catalan R, Valero S, Wykes T, Fatjo-Vilas M, Arias B. Changes in BDNF methylation patterns after cognitive remediation therapy in schizophrenia: A randomized and controlled trial. J Psychiatr Res. 2024 May;173:166-174. doi: 10.1016/j.jpsychires.2024.03.014. Epub 2024 Mar 23.

  PMID: 38537483 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Gene Regulatory Networks

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Regulatory Sequences, Nucleic Acid; Base Sequence; Genetic Structures; Genetic Phenomena

Study Officials

• Rafael Penadés, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study Procedure. 60 patients with schizophrenia disorder (according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, determined by The Structured Clinical Interview for DSM-5 (SCID-5) interview will be recruited and randomly allocated in one of the two groups: CRT or treatment as usual control group. All participants will undergo neurocognitive testing over a 2-week period, followed by a blood draw. After random allocation, 40 participants will follow a computerized cognitive remediation program and 20 will be followed a similar period of time without any cognitive intervention. Subjects will have another blood sample drawn after completion of the cognitive therapy or the TAU. All subjects should remain on stable doses of medications while in the study (no dose change \> 10%). Finally, subjects will be reassessed on PANSS and cognitive measures and social functioning by personnel blind to group assignment.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: January 3, 2017
• Primary Completion: May 5, 2020
• Study Completion: June 15, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

ES (1)