NCT05123872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 21, 2021

Last Update Submit

September 13, 2024

Conditions

Depression

Outcome Measures

Primary Outcomes (8)

  • 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

    6 weeks

  • 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

    6 weeks

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

    Number of days out of 30 the patients used the device

    6 weeks

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

    Number of patients who completed the treatment regulary

    6 weeks

  • 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

    6 weeks

  • 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)

    6 weeks

  • 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

    18 weeks

  • 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)

    18 weeks

Secondary Outcomes (7)

  • Hamilton depression rating scale

    18 weeks

  • Major Depression Inventory

    18 weeks

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

    18 weeks

  • Clincial Global Impression change

    18 weeks

  • Pittsburgh sleep quality index

    18 weeks

  • +2 more secondary outcomes

Study Arms (1)

prefrontal tDCS at home

EXPERIMENTAL

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

Device: tDCS

Interventions

tDCSDEVICE

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

prefrontal tDCS at home

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Berthold Langguth, PhD

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, MD, Ph.D.

Study Record Dates

First Submitted

September 21, 2021

First Posted

November 17, 2021

Study Start

November 1, 2021

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)