Depression
Conditions
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.
Interventions
DEVICEtDCS
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
Sponsors
neurocare group AG
University of Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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)) | 18 weeks | Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items) |
| Usability for the patients | 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 |
| Usability for the handlers/clinicians | 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 |
| Compliance 1 (Number of days out of 30 the patients used the device) | 6 weeks | Number of days out of 30 the patients used the device |
| Compliance 2 (Number of patients who completed the treatment regulary) | 6 weeks | 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) | 6 weeks | 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)) | 6 weeks | 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) | 18 weeks | Number of responders according the the clinical global impression change score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Depression Inventory | 18 weeks | Depression inventory (0-50, the lower the better) |
| WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF) | 18 weeks | Quality of life scale inventory (4-20, the higher the better) |
| Clincial Global Impression change | 18 weeks | Clincial Global Impression (1-7, the lower the better) |
| Pittsburgh sleep quality index | 18 weeks | sleep inventory (0-21, the lower the better) |
| Depression anxiety stress scale (DASS) | 18 weeks | Depression, anxiety and stress inventory (each 0-21, the lower the better) |
| Personality styles and disorder inventory | 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) |
| Hamilton depression rating scale | 18 weeks | Depression rating scale (0-65, the lower the better) |
Countries
Germany
Outcome results
None listed