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NCT Number: NCT05732298

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy

Regensburg, 93053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittend theta burst stimulation (iTBS)

Device

600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday

Other names: repetitive transcranial magnetic stimulation

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 8 weeks

    Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)

Secondary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 20 weeks

    Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)

  2. Major Depression Inventory

    Time frame: 20 weeks

    Major Depression Inventory (range: 0-50; higher values = worse outcome)

  3. World Health Organisation quality of life bref

    Time frame: 20 weeks

    World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)

  4. State Trait Anxiety Inventory

    Time frame: 20 weeks

    State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome)

  5. clinical global impression

    Time frame: 20 weeks

    clinical global impression (range: 0-7; higher values = worse outcome)

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

Acronym: TRUST

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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