NCT07228468

Brief Summary

Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether home-based tDCS is an effective treatment for major depression for adults with major depression. Participants will be randomised to receive either a 10-week course of active tDCS treatment in addition to their standard care (Treatment as Usual), or to only receive Treatment as Usual. Participants will be followed up for 6-months after the start of the treatment began. After the 6-month follow-up visit, all participants from both groups can choose to continue/start the tDCS treatment. There will be a final follow-up visit 3 months later (9 months from the original treatment start of the trial).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

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

Study Progress19%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 26, 2026

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 13, 2025

Last Update Submit

January 23, 2026

Conditions

Major Depressive Disorder (MDD)

Keywords

transcranial direct current stimulationtDCSmajor depressionMDDmajor depressive disorderbrain stimulation

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Ă…sberg Depression Rating Scale (MADRS)

    To evaluate tDCS clinical effectiveness as the difference in depressive symptom severity at end of 10-week treatment period between two treatment arms: those receiving treatment as usual (TAU) alone and those receiving TAU plus tDCS

    10 weeks

Secondary Outcomes (11)

  • Montgomery-Ă…sberg Depression Rating Scale (MADRS)

    6 months

  • Hamilton Depression Rating Scale (HDRS)

    10 weeks

  • Hamilton Anxiety Rating Scale (HAMA)

    10 weeks

  • Montgomery-Ă…sberg Depression Rating Scale-Self Report (MADRS-S)

    10 weeks

  • Hamilton Depression Rating Scale (HDRS)

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Treatment as usual (TAU)

NO INTERVENTION

Treatment as usual will consist of standard care, such as psychotherapy and/or antidepressant medication or no treatment, as decided by participant and treating clinician.

transcranial direct current stimulation + treatment as usual (tDCS + TAU)

EXPERIMENTAL

In addition to receiving treatment as usual, participants randomized to receive tDCS will engage in a 10-week treatment protocol of active tDCS which participants will administer at home. Stimulation schedule is 5 sessions per week for 3 weeks followed by 3 sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS device is headset with bifrontal montage, anode at left dorsolateral prefrontal cortex (DLPFC) and cathode at right DLPFC (EEG positions F3 and F4, respectively). Stimulation is 2 mA for 30 minutes with a gradual ramp up over 30 seconds. Electrode area is 23 cm2.

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS)DEVICE

Participants randomised to the tDCS treatment arm will use a tDCS device which is a headset with the anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4, respectively). Treatment protocol consists of 5 tDCS sessions per week for 3 weeks followed by 3 tDCS sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS stimulation is 2 mA for 30 minutes with gradual ramp up over 30 seconds at the start and end of each session.

transcranial direct current stimulation + treatment as usual (tDCS + TAU)

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or over
  • Current episode of depression based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (APA, 2013) for major depressive disorder (MDD) as assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998)
  • Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS
  • Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
  • Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.
  • Being under the care of GP
  • Agreeable for GP to be regularly informed about study participation
  • Able to provide written, informed consent

You may not qualify if:

  • Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011)
  • Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI
  • Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
  • Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of 8 or more in Alcohol use disorders identification test consumption (AUDIT C) (Khadjesari et al., 2017; NICE, 2023)
  • History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation
  • History of esketamine / ketamine for treatment of depression
  • History of psychosurgery for depression
  • Having cognitive impairment (e.g. dementia)
  • Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease)
  • Have any implant in the brain or neurocranial defect
  • Have shrapnel or any ferromagnetic material in the head
  • Have any active implantable medical device (e.g. pacemaker)
  • If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study
  • Concurrent enrolment in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cardiff and Vale Health Board

Cardiff, CF24 4HQ, United Kingdom

NOT YET RECRUITING

South London and Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

RECRUITING

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle, NE4 5PL, United Kingdom

NOT YET RECRUITING

Northamptonshire Healthcare NHS Foundation Trust

Northampton, NN5 6UD, United Kingdom

NOT YET RECRUITING

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, NG7 2UH, United Kingdom

NOT YET RECRUITING

Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Southampton, SO14 3DT, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Cynthia Fu, MD, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Fu

CONTACT

020 7848 0002cynthia.fu@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive active transcranial direct current stimulation (tDCS) OR treatment as usual (TAU).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 26, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Anonymised data will be made available on request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
a maximum of 1 year after publication of study results
Access Criteria
Individual access by request

Locations

GB(6)