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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Device: intermittend theta burst stimulation (iTBS)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • Department of Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Regensburg
• Investigators: Principal Investigator: Berthold Langguth, Prof., University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 22-3053-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No