Could a headset lift depression? new trial tests home Brain-Zap therapy
NCT ID NCT07611773
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests whether a high-dose version of a gentle brain-stimulation device (tDCS) used at home works better than the standard dose for easing major depression. About 270 adults with depression will use the device daily and be monitored for changes in mood and thinking. The study also looks at brain-wave patterns to see if they can predict who benefits most.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged 18 years or over. * Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013). * Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960). * Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks. * Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer. * Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant. * Have the ability and willingness to commit to the study team to complete all phases of the study. * Volunteer to participate and sign the specific informed consent form for this study. Exclusion Criteria: * Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale. * Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool. * Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration. * Any previous hospitalisation for suicidal behaviour. * Presenting with current chronic or severe insomnia (\< 4 hours' sleep per night) or sleep apnoea. * Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator. * History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment. * History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders. * Any exclusion criteria other than those established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): * Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers * Brain stimulation within the last 6 months. * Clinical or family history of epilepsy or seizure episodes. * Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.) * History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine). * Pending trial or litigation during the course of the trial. * Pregnancy.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Hospital Universiatrio Doctor Peset
RECRUITINGValencia, Spain
Contact Email: •••••@•••••
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