Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment (TRUST)

University of Regensburg (UR)

Status

Active, not recruiting

Conditions

Depression

Treatments

Device: intermittend theta burst stimulation (iTBS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05732298

22-3053-101

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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