Accelerated Treatment of Depressive Patients With tDCS

NCT07444242 | Not Yet Recruiting

• 1 other identifier: 25-4450-101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Major Depressive Disorder

Keywords

Depression; tDCS; Accelerated

Outcome Measures

Primary Outcomes (3)

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

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

  3 weeks

• Course of the scores of the Major Depression Inventory

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

  3 weeks

• Compliance

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

  3 weeks

Study Arms (3)

Verum accelerated home-based tDCS

EXPERIMENTAL

10 patients will receive active tDCS during a three-week intervention (accelerated: twice daily).

Device: Transcranial direct current stimulation

Sham accelerated home-based tDCS

PLACEBO COMPARATOR

10 patients will receive sham tDCS during a three-week intervention (accelerated: twice daily) with the opportunity to get active tDCS after study completion.

Device: Transcranial direct current stimulation

Waiting list

NO INTERVENTION

10 patients will have to wait for three weeks before the beginning ot the active tDCS intervention.

Interventions

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).

Also known as: tDCS

Sham accelerated home-based tDCS; Verum accelerated home-based tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Berthold Langguth, Prof, PhD

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Schoisswohl, PD, PhD

CONTACT

+499419411284; stefan.schoisswohl@ukr.de

Ulrike Stadler

CONTACT

+499419411256; tms-psy-r@medbo.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Random allocation to the three groups will be performed by chance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD, Ph.D.

Model Details: Thirty patients will be randomly assigned to one of three study arms (n = 10 per group): active (verum) tDCS, sham (placebo) tDCS, or a waitlist control group. The latter two groups will subsequently be given the opportunity to receive active tDCS treatment.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share