Clinical trial NCT05123872: Transcranial Direct Current Stimulation as Home Treatment in Depression
Official title: GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: neurocare group AG
First posted: 2021-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability for the patients
timeFrame: 6 weeks
measure: Usability for the handlers/clinicians
timeFrame: 6 weeks
measure: Compliance 1 (Number of days out of 30 the patients used the device)
timeFrame: 6 weeks
measure: Compliance 2 (Number of patients who completed the treatment regulary)
timeFrame: 6 weeks
measure: Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis)
timeFrame: 6 weeks
measure: Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
timeFrame: 6 weeks
measure: Stability of effects 1 (Number of responders according the the clinical global impression change score)
timeFrame: 18 weeks
measure: 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))
timeFrame: 18 weeks
Secondary outcomes:
measure: Hamilton depression rating scale
timeFrame: 18 weeks
measure: Major Depression Inventory
timeFrame: 18 weeks
measure: WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
timeFrame: 18 weeks
measure: Clincial Global Impression change
timeFrame: 18 weeks
measure: Pittsburgh sleep quality index
timeFrame: 18 weeks
measure: Depression anxiety stress scale (DASS)
timeFrame: 18 weeks
measure: Personality styles and disorder inventory
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, PhD
role: PRINCIPAL_INVESTIGATOR
References: