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Transcranial Direct Current Stimulation as Home Treatment in Depression (GSUND_DAHOAM)

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Regensburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prefrontal tDCS at home

Arm Description

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

Outcomes

Primary Outcome Measures

Usability for the patients
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
Usability for the handlers/clinicians
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
Compliance 1 (Number of days out of 30 the patients used the device)
Number of days out of 30 the patients used the device
Compliance 2 (Number of patients who completed the treatment regulary)
Number of patients who completed the treatment regulary
Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis)
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Stability of effects 1 (Number of responders according the the clinical global impression change score)
Number of responders according the the clinical global impression change score
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))
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

Secondary Outcome Measures

Hamilton depression rating scale
Depression rating scale (0-65, the lower the better)
Major Depression Inventory
Depression inventory (0-50, the lower the better)
WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Clincial Global Impression change
Clincial Global Impression (1-7, the lower the better)
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
Depression anxiety stress scale (DASS)
Depression, anxiety and stress inventory (each 0-21, the lower the better)
Personality styles and disorder inventory
Depedence of treatment effect from personality as measured with the Personality styles and disorder inventory (PSDI) (T-value norms, values around 50 are normal)

Full Information

First Posted
September 21, 2021
Last Updated
February 7, 2023
Sponsor
University of Regensburg
Collaborators
neurocare group AG
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1. Study Identification

Unique Protocol Identification Number
NCT05123872
Brief Title
Transcranial Direct Current Stimulation as Home Treatment in Depression
Acronym
GSUND_DAHOAM
Official Title
GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
Collaborators
neurocare group AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prefrontal tDCS at home
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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 Outcome Measure Information:
Title
Usability for the patients
Description
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
Time Frame
6 weeks
Title
Usability for the handlers/clinicians
Description
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
Time Frame
6 weeks
Title
Compliance 1 (Number of days out of 30 the patients used the device)
Description
Number of days out of 30 the patients used the device
Time Frame
6 weeks
Title
Compliance 2 (Number of patients who completed the treatment regulary)
Description
Number of patients who completed the treatment regulary
Time Frame
6 weeks
Title
Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis)
Description
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Time Frame
6 weeks
Title
Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
Description
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
Title
Stability of effects 1 (Number of responders according the the clinical global impression change score)
Description
Number of responders according the the clinical global impression change score
Time Frame
18 weeks
Title
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))
Description
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
Secondary Outcome Measure Information:
Title
Hamilton depression rating scale
Description
Depression rating scale (0-65, the lower the better)
Time Frame
18 weeks
Title
Major Depression Inventory
Description
Depression inventory (0-50, the lower the better)
Time Frame
18 weeks
Title
WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Description
Quality of life scale inventory (4-20, the higher the better)
Time Frame
18 weeks
Title
Clincial Global Impression change
Description
Clincial Global Impression (1-7, the lower the better)
Time Frame
18 weeks
Title
Pittsburgh sleep quality index
Description
sleep inventory (0-21, the lower the better)
Time Frame
18 weeks
Title
Depression anxiety stress scale (DASS)
Description
Depression, anxiety and stress inventory (each 0-21, the lower the better)
Time Frame
18 weeks
Title
Personality styles and disorder inventory
Description
Depedence of treatment effect from personality as measured with the Personality styles and disorder inventory (PSDI) (T-value norms, values around 50 are normal)
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, PhD
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93055
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation as Home Treatment in Depression

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