Clinical trial NCT04278027: Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics
Official title: Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Cognitive Remediation
Epigenetics
BDNF
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: Instituto de Salud Carlos III
First posted: 2020-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in methylation at Cytosine-phosphate-Guanine (CpG) exon
timeFrame: Baseline and after 4 months
measure: Change in methylation at CpG exon IV
timeFrame: Baseline and after 4 months
Secondary outcomes:
measure: Change in cognition
timeFrame: Baseline and after 4 months
measure: Change in Symptoms
timeFrame: Baseline and after 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Rafael Penadés, PhD
role: PRINCIPAL_INVESTIGATOR
References: