Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

Conditions
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Depression

Intervention / Treatment
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* Device: intermittend theta burst stimulation (iTBS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active treatment<br>intermittent theta burst stimulation | Device: intermittend theta burst stimulation (iTBS)<br>* 600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday<br>* Other names: repetitive transcranial magnetic stimulation;|
| No Intervention: waiting list<br>patients waiting for intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 20 weeks | 
| Major Depression Inventory | Major Depression Inventory (range: 0-50; higher values = worse outcome) | 20 weeks | 
| World Health Organisation quality of life bref | World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome) | 20 weeks | 
| State Trait Anxiety Inventory | State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome) | 20 weeks | 
| clinical global impression | clinical global impression (range: 0-7; higher values = worse outcome) | 20 weeks |