Major Depressive Disorder
Conditions
Keywords
Depression, tDCS, Accelerated
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).
Detailed description
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.
Interventions
DEVICETranscranial direct current stimulation
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).
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Random allocation to the three groups will be performed by chance.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of the scores of the Hamilton Depression rating scale (21 Items) | 3 weeks | Depression rating scale (0-65, the lower the better) |
| Course of the scores of the Major Depression Inventory | 3 weeks | Depression rating scale (0-50, the lower the better) |
| Compliance | 3 weeks | Number of treatments administered (0-30 sessions, the more the better) |
Countries
Germany
Contacts
CONTACTStefan Schoisswohl, PD, PhD
CONTACTUlrike Stadler
PRINCIPAL_INVESTIGATORBerthold Langguth, Prof, PhD
University of Regensburg
Outcome results
None listed