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Accelerated Treatment of Depressive Patients With tDCS

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Regensburg

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Verum accelerated home-based tDCSExperimental treatment 1 intervention
Group B: Sham accelerated home-based tDCSPlacebo comparator 1 intervention
Group C: Waiting listNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
3 weeks
2

Course of the scores of the Major Depression Inventory

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

Time frame
3 weeks
3

Compliance

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

Time frame
3 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Regensburg

Lead sponsor

Source ClinicalTrials.gov
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