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NCT Number: NCT07444242

Accelerated Treatment of Depressive Patients With tDCS

A randomized, controlled three-arm study is planned to investigate the effectiveness and feasibility of an accelerated home-based tDCS application (3 weeks of transcranial direct current stimulation at home, twice daily). A total of 30 patients with depression (10 per group), who are currently not taking and have no history of taking antidepressant medication, will be randomly assigned to either an active tDCS condition, a sham (placebo) tDCS condition, or a waitlist control group. The latter two groups will receive active tDCS treatment after completion of the control phase.

This study represents a continuation of the pilot study GSUND DAHOAM (Ethics approval: 20-2091-101; Dragon et al., 2024).

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The aim of this study is to evaluate the feasibility of home-based tDCS for the accelerated treatment (twice daily) of depressive disorders (GSUND DAHOAM 2.0 = continuation of the study "GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise zur Medbo"; Dragon et al., 2024).

Specifically, the study will assess feasibility (device usability, patient compliance, and usability of the video consultation), effectiveness (clinical ratings), and tolerability of this intervention in 30 patients with depression. Participants will be randomly assigned to one of three groups: active tDCS treatment, sham (placebo) tDCS treatment, or a waitlist control group (waiting period: 3 weeks). The latter two groups will subsequently receive active tDCS treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sex: female, male, non-binary
  • Age: 18-70 years
  • Diagnosis of depression: no current or past psychiatric medication (current episode and history)
  • Provision of informed consent to participate
  • Sufficient proficiency in the German language

Exclusion criteria

  • Presence of contraindications for tDCS (e.g., electrical implants or metallic objects in the body such as a cardiac pacemaker or insulin pump, dermatological conditions affecting the scalp)
  • Neurological disorders (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformations, or a history of severe head injury)
  • Participation in another clinical trial on depression within the 3 months prior to treatment initiation
  • Pregnancy or breastfeeding

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), have gained increasing attention in recent years in both research and the treatment of various psychiatric disorders (Alonzo et al., 2019; Lefaucher et al., 2017).

Compared to other neuromodulation methods, such as transcranial magnetic stimulation (TMS), tDCS offers the advantage of mobile or outpatient use, including home-based application. tDCS devices are small, portable, and cost-effective, and they are associated with a favorable side-effect profile (Alonzo et al., 2019).

Other names: tDCS

Primary outcomes

  1. Course of the scores of the Hamilton Depression rating scale (21 Items)

    Time frame: 3 weeks

    Depression rating scale (0-65, the lower the better)

  2. Course of the scores of the Major Depression Inventory

    Time frame: 3 weeks

    Depression rating scale (0-50, the lower the better)

  3. Compliance

    Time frame: 3 weeks

    Number of treatments administered (0-30 sessions, the more the better)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Schoisswohl, PD, PhD

CONTACT

[email protected]

+499419411284

Ulrike Stadler

CONTACT

[email protected]

+499419411256

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Accelerated Treatment of Depressive Patients With tDCS (Twice Per Day) - a Placebo Controlled Home-based Treatment

Acronym: AcctDCS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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