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

Sponsor
University of Regensburg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05732298
Collaborator
(none)
72
Enrollment
2
Arms
25.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: intermittend theta burst stimulation (iTBS)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
Anticipated Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton Depression Rating Scale [8 weeks]

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

    Secondary Outcome Measures

    1. Hamilton Depression Rating Scale [20 weeks]

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

    2. Major Depression Inventory [20 weeks]

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

    3. World Health Organisation quality of life bref [20 weeks]

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

    4. State Trait Anxiety Inventory [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 [20 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Regensburg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Berthold Langguth, MD, Ph.D., Prof. Dr., University of Regensburg
    ClinicalTrials.gov Identifier:
    NCT05732298
    Other Study ID Numbers:
    • 22-3053-101
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Feb 22, 2023