testslug trial title

  • STATUS
    Recruiting
  • participants needed
    114
  • sponsor
    Mor Nahum
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Updated on 9 July 2021
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Summary

Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; up to 40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. Up to 25% of patients manifest a chronic course of illness, resulting in a need for additional treatment options.
The DiSCoVeR trial is a multi-site, double-blind, sham-controlled, proof-of concept randomized controlled trial (RCT). The study aims to investigate the feasibility and efficacy of an innovative, combined treatment approach, incorporating transcranial direct current stimulation (tDCS) along with a custom-made video game designed to enhance cognitive control in patients with major depressive disorder (MDD).
Patients diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS along with an active videogame or sham tDCS + sham game for 6 weeks. Follow-up per patient is 6 weeks following treatment. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of symptom changes.

Description

Major Depressive Disorder (MDD) is a prevalent, seriously impairing, and often recurrent mental disorder. It has been ranked as a leading cause of disability worldwide by the World Health Organization (WHO) as measured by years lived with disability.
A considerable number of patients with MDD experience a chronic course of illness and approximately one third of MDD patients do not respond sufficiently to pharmacological treatment, calling for treatment alternatives.
Non-invasive brain stimulation techniques (NIBS) such as tDCS targeting prefrontal cortical areas have emerged as a safe, promising, and cost-effective alternative to traditional treatment options in patients with MDD.
This study focuses not only on an overall reduction of depressive symptoms, but also an alleviation of cognitive control deficits in particular, since patients with MDD often suffer from cognitive control deficits. tDCS has been shown to directly modulate cognitive control functions in healthy participants and in depressed patients. Another approach to directly modulate cognitive control functions is cognitive control training.
In the present study, an engaging and captivating cognitive control training designed as an action video game will be employed. The primary objective is to test the feasibility and efficacy of this innovative, combined treatment approach for self application, concurrently applying both interventions (tDCS + cognitive control training) in patients suffering from MDD. Additionally, participants have the opportunity to choose to take part in two adjunctive assessments: a biological assessment which includes salivary samples and a multimodal imaging paradigm (fMRI).

Details
Condition major depressive disorder, Endogenous depression, Major depression
Age 18years - 65years
Treatment Active tDCS, Sham tDCS, cognitive and emotional control video game, sham video game
Clinical Study IdentifierNCT04953208
SponsorMor Nahum
Last Modified on9 July 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and woman 18-65 years of age
Primary Diagnostic and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD), with a single or recurrent episode with the additional requirement of a current episode with a duration of 4 weeks
Current depressive episode lasts less than 5 years (the current and previous depressive episodes are demarcated by a period of 2 months in which the patient did not meet full criteria for the DSM-5 definition of MDD)
Total Hamilton-21 score 13 at screening visit
Capable and willing to provide informed consent. Patients without antidepressant medication or patients on an adequate (i.e., at least lowest effective) and stable (i.e., for 6 weeks) dosage of SSRI (Escitalopram, Citalopram, Sertralin, Paroxetin, Fluvoxamin, Fluoxetin), SSNRI (Duloxetin, Venlafaxin) or Others (Mirtazapin, Agomelatin, Vortioxetine)
Concomitant psychotherapy is allowed if ongoing for at least 3 months prior to baseline

Exclusion Criteria

Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption)
Addiction to gaming as assessed by the Gaming Disorder Test (GDT)
Individuals diagnosed with the following psychiatric conditions (current unless otherwise stated)
Depression assessed as secondary to a general medical condition or substance-induced
Substance abuse or substance dependence (except nicotine, caffeine) in the last 6 months
Psychotic disorder (lifetime)
Bipolar disorder (I and II; lifetime)
Eating disorder if stated as primary diagnosis
Obsessive compulsive disorder if stated as primary diagnosis
Post-traumatic stress disorder if stated as primary diagnosis
Generalized anxiety disorder if stated as primary diagnosis
Panic disorder/ social anxiety if stated as primary diagnosis
Personality disorder if stated as primary diagnosis
Individuals diagnosed with a significant neurological disorder or insult including, but not limited to
Increased intracranial pressure
Space occupying brain lesion
History of cerebrovascular accident
Transient ischemic attack within two years
Cerebral aneurysm, dementia
Parkinson's disease
Huntington's chorea
Multiple sclerosis
Epilepsy
Electroconvulsive therapy (ECT) treatment in current episode
History of tDCS, except for single tDCS sessions in experimental studies
Use of any investigational drug within 6 weeks from baseline
Suicidal risk based on MADRS item 10 score of 4-6 or attempted suicide in current episode
Acute, unstable cardiac disease
Intracranial implant or any other metal object within or near the head (excluding the mouth) that cannot be safely removed; implanted neuro-stimulators
Known or suspected pregnancy (according to pregnancy test), and women of childbearing potential not using effective contraception
History of seizures
Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants)
Any relevant unstable medical condition (e.g. acute, unstable cardiac disease)
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