Depression
Conditions
Brief summary
This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS). This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks). The patients to be treated are those who refuse treatment with antidepressant medications. The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a watchful waiting after 4 weeks. A interim analysis is planned after 36 patients.
Interventions
DEVICEintermittend theta burst stimulation (iTBS)
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* uni- or bipolar depression according to ICD-10 * present episode at least four weeks * 18-70 years old * no intake and rejection of anti-depressant medication and * no adequate anti-depressant medication in the present episode * no or stable non-drug anti-depressant treatment (e.g. psychotherapy) * residency in Germany, German speaking
Exclusion criteria
* contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker * relevant neurological or internistic diseases according to study investigator * participation in other trials during treatment * pregnancy or breatfeeding * legal care and placement in a psychiatric hospital * active suicidality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | 8 weeks | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | 20 weeks | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) |
| Major Depression Inventory | 20 weeks | Major Depression Inventory (range: 0-50; higher values = worse outcome) |
| World Health Organisation quality of life bref | 20 weeks | World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome) |
| State Trait Anxiety Inventory | 20 weeks | State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome) |
| clinical global impression | 20 weeks | clinical global impression (range: 0-7; higher values = worse outcome) |
Countries
Germany
Outcome results
None listed