Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

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.

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