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Completed

NCT Number: NCT05123872

Transcranial Direct Current Stimulation as Home Treatment in Depression

In this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

About this study

In this one-armed study at least 10 patients with depression will be included who will get treatment with transcranial direct currect stimulation at home. One visit in the hospital before and one visit after the treatment are necessary. The correct application of the device by the patients will be ensured by video counseling and monitoring. Treatment will last six weeks with 2 mA applied every working day for 20min with prefrontal montage.

Aim of the study is the evaluation of the feasibility of this home treatment (usability of the device, compliance of patients, usability of the video contacts), the effectiveness (clinical ratings) and the tolerability of this treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • depressive episode according to ICD-10
  • moderate depression according to clinical impression or Hamilton depression rating scale
  • gender: all sexes
  • age: 18-70 years
  • stable medication if possible
  • no or stable treatment of depression
  • residence in Germany and mother language German
  • written informed consent

Exclusion criteria

  • contraindications for transcranial direct current stimulation
  • neurological conditions
  • participiation in another study
  • pregnancy and lactation period

Treatment and study plan

tDCS

Device

trancranial direct current stimulation 30 sessions within 6 weeks (treatment on working days) 2mA with cathode on the right and anode an the left side

Primary outcomes

  1. Usability for the patients

    Time frame: 6 weeks

    Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better] and open feedback

  2. Usability for the handlers/clinicians

    Time frame: 6 weeks

    Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better] and open feedback

  3. Compliance 1 (Number of days out of 30 the patients used the device)

    Time frame: 6 weeks

    Number of days out of 30 the patients used the device

  4. Compliance 2 (Number of patients who completed the treatment regulary)

    Time frame: 6 weeks

    Number of patients who completed the treatment regulary

  5. Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis)

    Time frame: 6 weeks

    Number of responders according the the clinical global impression change score for patients in the per protocol analysis

  6. Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))

    Time frame: 6 weeks

    Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

  7. Stability of effects 1 (Number of responders according the the clinical global impression change score)

    Time frame: 18 weeks

    Number of responders according the the clinical global impression change score

  8. Stability of effects 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))

    Time frame: 18 weeks

    Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

Secondary outcomes

  1. Hamilton depression rating scale

    Time frame: 18 weeks

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

  2. Major Depression Inventory

    Time frame: 18 weeks

    Depression inventory (0-50, the lower the better)

  3. WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)

    Time frame: 18 weeks

    Quality of life scale inventory (4-20, the higher the better)

  4. Clincial Global Impression change

    Time frame: 18 weeks

    Clincial Global Impression (1-7, the lower the better)

  5. Pittsburgh sleep quality index

    Time frame: 18 weeks

    sleep inventory (0-21, the lower the better)

  6. Depression anxiety stress scale (DASS)

    Time frame: 18 weeks

    Depression, anxiety and stress inventory (each 0-21, the lower the better)

  7. Personality styles and disorder inventory

    Time frame: 18 weeks

    Depedence of treatment effect from personality as measured with the Personality styles and disorder inventory (PSDI) (T-value norms, values around 50 are normal)

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Collaborators

  • neurocare group AG

Registry information

Official study title

GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)

Acronym: GSUND_DAHOAM

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 17, 2021
Registry last updated
Sep 19, 2024

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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