NCT04953208

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

June 7, 2021

Last Update Submit

January 17, 2024

Conditions

Major Depressive Disorder

Keywords

cognitive controlnon-invasive brain stimulation, transcranial direct current stimulationVideoGameself-applicationhome-basedfeasibilityefficacy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of treatment

    Feasibility is met if a patient will complete 20 sessions per protocol with a probability of more than 50.00%.Completion per protocol is achieved, if the patient completes 20 sessions per protocol with a probability of more than 50 percent.

    Six weeks

Secondary Outcomes (1)

  • Efficacy-Improvement on the MADRS scores compared to baseline.

    six weeks

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

active tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game

Device: active tDCSBehavioral: cognitive and emotional control video game

Sham treatment

SHAM COMPARATOR

sham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame

Device: sham tDCSBehavioral: sham video game

Interventions

active tDCSDEVICE

Treatment will be applied daily 5 days/week for a period of 6 weeks, which equals a tDCS stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Active treatment
sham tDCSDEVICE

sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Sham treatment
cognitive and emotional control video gameBEHAVIORAL

a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Active treatment
sham video gameBEHAVIORAL

a video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Sham treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ludwig-Maximilian University

Munich, 80336, Germany

NOT YET RECRUITING

Hadassah University Hospital

Jerusalem, 12000, Israel

NOT YET RECRUITING

Riga Stradins University (RSU)

Riga, Latvia

RECRUITING

Related Publications (10)

  • Padberg F, Bulubas L, Mizutani-Tiebel Y, Burkhardt G, Kranz GS, Koutsouleris N, Kambeitz J, Hasan A, Takahashi S, Keeser D, Goerigk S, Brunoni AR. The intervention, the patient and the illness - Personalizing non-invasive brain stimulation in psychiatry. Exp Neurol. 2021 Jul;341:113713. doi: 10.1016/j.expneurol.2021.113713. Epub 2021 Mar 31.

    PMID: 33798562RESULT

  • Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.

    PMID: 16554525RESULT

  • Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

    PMID: 28657871RESULT

  • Padberg F, Kumpf U, Mansmann U, Palm U, Plewnia C, Langguth B, Zwanzger P, Fallgatter A, Nolden J, Burger M, Keeser D, Rupprecht R, Falkai P, Hasan A, Egert S, Bajbouj M. Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC). Eur Arch Psychiatry Clin Neurosci. 2017 Dec;267(8):751-766. doi: 10.1007/s00406-017-0769-y. Epub 2017 Feb 28.

    PMID: 28246891RESULT

  • De Raedt R, Koster EH. Understanding vulnerability for depression from a cognitive neuroscience perspective: A reappraisal of attentional factors and a new conceptual framework. Cogn Affect Behav Neurosci. 2010 Mar;10(1):50-70. doi: 10.3758/CABN.10.1.50.

    PMID: 20233955RESULT

  • Wolkenstein L, Plewnia C. Amelioration of cognitive control in depression by transcranial direct current stimulation. Biol Psychiatry. 2013 Apr 1;73(7):646-51. doi: 10.1016/j.biopsych.2012.10.010. Epub 2012 Dec 6.

    PMID: 23219367RESULT

  • Calkins AW, McMorran KE, Siegle GJ, Otto MW. The Effects of Computerized Cognitive Control Training on Community Adults with Depressed Mood. Behav Cogn Psychother. 2015 Sep;43(5):578-89. doi: 10.1017/S1352465814000046. Epub 2014 Mar 3.

    PMID: 24589123RESULT

  • Bavelier D, Green CS. Enhancing Attentional Control: Lessons from Action Video Games. Neuron. 2019 Oct 9;104(1):147-163. doi: 10.1016/j.neuron.2019.09.031.

    PMID: 31600511RESULT

  • Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.

    PMID: 27362792RESULT

  • Dechantsreiter E, Padberg F, Morash A, Kumpf U, Nguyen A, Menestrina Z, Windel F, Burkhardt G, Goerigk S, Morishita T, Soldini A, Ahissar S, Cohen T, Pasqualotto A, Rubene L, Konosonoka L, Keeser D, Zill P, Assi R, Gardier R, Vinals R, Thiran JP, Segman R, Benjamini Y, Bonne O, Hummel FC, Bavelier D, Rancans E, Nahum M. Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):85-98. doi: 10.1007/s00406-022-01464-y. Epub 2022 Oct 22.

    PMID: 36271928DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Mor Nahum, PhD

CONTACT

0547326655mor.nahum@mail.huji.ac.il

Omer Bonne, Professor Medical Doctor

CONTACT

bonne@hadassah.org.il

Study Design

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

Study Record Dates

First Submitted

June 7, 2021

First Posted

July 7, 2021

Study Start

June 22, 2021

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)DE(1)IL(1)