Major Depressive DisorderNCT04953208
Remotely Non-invasive Brain Stimulation and Videogame to Alleviate Depression
A study testing active tDCS in people with Major Depressive Disorder, run by Mor Nahum at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- active tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Jun 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 33Show fewer
- 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)
Trial locations and contacts
3 sites in 3 countries.
Omer Bonne, Professor Medical Doctor contact
3 sites in 3 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Ludwig-Maximilian University
Munich, 80336
Esther Dechantsreiter, Esther.Dechantsreiter@med.uni-muenchen.de
Frank Padberg, M.D.
Israel1 site, 1 recruiting
- Not yet recruiting
Hadassah University Hospital
Jerusalem, 12000
Alon Morash, alonmorash@gmail.com
Omer Bonne, M.D.
Latvia1 site, 1 recruiting
- Recruiting
Riga Stradins University (RSU)
Riga
Linda Rubene, M.D., lindarubene93@gmail.com
Elmars Rancans, M.D.
About this study
Official title: The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression
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.
Read the detailed 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 (structural and functional sequences, including an interleaved TMS-fMRI paradigm).
- Conditions
- Major Depressive Disorder
- Being tested
- active tDCS, sham tDCS, cognitive and emotional control video game, sham video game
- Keywords
- cognitive control, non-invasive brain stimulation, transcranial direct current stimulation, VideoGame, self-application, home-based, feasibility, efficacy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
sham tDCSDevice
sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
cognitive and emotional control video gameBehavioural
a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
sham video gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | active tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game Receives: Device: active tDCS; Behavioral: cognitive and emotional control video game |
| Sham treatment | Sham comparator | sham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame Receives: Device: sham tDCS; Behavioral: sham video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
Secondary outcomes (1)
Efficacy-Improvement on the MADRS scores compared to baseline.
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline.
The MADRS scores severity of depression on a scale from 0-60. Higher scores indicate worse depression. A total score between 0-6 indicates that the patient is in the normal range (no depression), 7-19 indicates mild depression, 20-34 indicates moderate depression, and a score of 35 and greater indicates severe depression.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start22 Jun 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mor Nahum
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization, Ludwig-Maximilians - University of Munich, Riga Stradins University
- Responsible party
- Sponsor-investigator, Mor Nahum, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953208
- Sponsor's protocol ID
- 388-20-HMO
- Status last verified
- Jan 2024
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33798562Rush 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.
PubMed 16554525Brunoni 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.
PubMed 28657871Padberg 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.
PubMed 28246891De 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.
PubMed 20233955Wolkenstein 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.
PubMed 23219367Calkins 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.
PubMed 24589123Bavelier 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.
PubMed 31600511Hoorelbeke 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.
PubMed 27362792Dechantsreiter E, Padberg F, Benjamini Y, Goerigk S, Rubene-Kesele L, Konosonoka L, Vogelmann U, Cohen T, Lerner N, Burkhardt G, Soldini A, Windel F, Fanourakis M, Menestrina Z, Nguyen A, Pasqualotto A, Morishita T, Dotan A, Ahissar S, Morash A, Bjorklund J, Bulubas L, Keeser D, Assa N, Gardier R, Vinals R, Thiran JP, Segman R, Bonne O, Lotan A, Hummel FC, Rancans E, Bavelier D, Nahum M. Home Transcranial Direct Current Stimulation With Gamified Cognitive Control Training for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639400. doi: 10.1001/jamanetworkopen.2026.39400.
PubMed 42895746Rubene-Kesele L. Implementation Burden and Hidden Labor in a Multisite Digital Psychiatry Trial. Healthcare (Basel). 2026 May 22;14(11):1430. doi: 10.3390/healthcare14111430.
PubMed 42278683Dechantsreiter 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.
PubMed 36271928
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression
- ClinicalTrials.gov ID
- NCT04953208
- Acronym / sponsor ID
- 388-20-HMO
- Conditions
- Major Depressive Disorder
- Keywords
- cognitive control, non-invasive brain stimulation, transcranial direct current stimulation, VideoGame, self-application, home-based, feasibility, efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Mor NahumUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization, Ludwig-Maximilians - University of Munich, Riga Stradins University
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 (structural and functional sequences, including an interleaved TMS-fMRI paradigm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Device: active tDCS, Behavioral: cognitive and emotional control video gameactive tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game |
| Sham treatment | Sham comparator | Device: sham tDCS, Behavioral: sham video gamesham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (33 listed)
- 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):
- Individuals diagnosed with a significant neurological disorder or insult including, but not limited to:
- Electroconvulsive therapy (ECT) treatment in current episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSTreatment 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. | Device | Active treatment |
| sham tDCSsham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention. | Device | Sham treatment |
| cognitive and emotional control video gamea video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention. | Behavioural | Active treatment |
| sham video gamea video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention. | Behavioural | Sham treatment |
Primary outcome
Feasibility of treatment
Time frame: Six weeks
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.
1 secondary outcome
Efficacy-Improvement on the MADRS scores compared to baseline.
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Results publication: PubMed 33798562Padberg 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.
- Results publication: PubMed 16554525Rush 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.
- Results publication: PubMed 28657871Brunoni 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.
- Results publication: PubMed 28246891Padberg 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.
- Results publication: PubMed 20233955De 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.
- Results publication: PubMed 23219367Wolkenstein 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.
- Results publication: PubMed 24589123Calkins 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.
- Results publication: PubMed 31600511Bavelier 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.
- Results publication: PubMed 27362792Hoorelbeke 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.
- Derived from this study: PubMed 42895746Dechantsreiter E, Padberg F, Benjamini Y, Goerigk S, Rubene-Kesele L, Konosonoka L, Vogelmann U, Cohen T, Lerner N, Burkhardt G, Soldini A, Windel F, Fanourakis M, Menestrina Z, Nguyen A, Pasqualotto A, Morishita T, Dotan A, Ahissar S, Morash A, Bjorklund J, Bulubas L, Keeser D, Assa N, Gardier R, Vinals R, Thiran JP, Segman R, Bonne O, Lotan A, Hummel FC, Rancans E, Bavelier D, Nahum M. Home Transcranial Direct Current Stimulation With Gamified Cognitive Control Training for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639400. doi: 10.1001/jamanetworkopen.2026.39400.
- Derived from this study: PubMed 42278683Rubene-Kesele L. Implementation Burden and Hidden Labor in a Multisite Digital Psychiatry Trial. Healthcare (Basel). 2026 May 22;14(11):1430. doi: 10.3390/healthcare14111430.
- Derived from this study: PubMed 36271928Dechantsreiter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Bonne, Professor Medical Doctor contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Major Depressive Disorder, run by Mor Nahum at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Israel, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mor Nahum, PhD (0547326655, mor.nahum@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of treatment (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953208, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.