Could a headset at home lift depression? new trial investigates
NCT ID NCT07510880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares the safety and effectiveness of using a mild electrical brain stimulation device (tDCS) at home versus at a clinic for treating major depression. About 198 adults with moderate to severe depression will use the device daily for a few weeks. Researchers will measure changes in depression scores to see if home treatment works as well as clinic treatment.
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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 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2027
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 to 65 years
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Spanish or Catalan speakers of both sexes between the ages of 18 and 65. * Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019). * Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable. * Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety. * Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion. Exclusion Criteria: * Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B). * Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment). * Any exclusion criteria 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 in the last 6 months. Clinical or family history of epilepsy. * Patients with dermatological problems, such as an allergic skin reaction at the electrode site. * High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016). * Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine). * Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting 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
3 sites. 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 Universitari de Mataró
RECRUITINGMataró, Barcelona, 08304, Spain
Contact Email: •••••@•••••
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Hospital Universitario de Bellvitge
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08304, Spain
Contact Email: •••••@•••••
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Parc Taulí Hospital Universitari
NOT_YET_RECRUITINGSabadell, Barcelona, 08208, Spain
Contact Email: •••••@•••••
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