Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

NCT05732298 | Active Not Recruiting

• 1 other identifier: 22-3053-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. A interim analysis is planned after 36 patients.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

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

  8 weeks

Secondary Outcomes (5)

• Hamilton Depression Rating Scale

  20 weeks

• Major Depression Inventory

  20 weeks

• World Health Organisation quality of life bref

  20 weeks

• State Trait Anxiety Inventory

  20 weeks

• clinical global impression

  20 weeks

Study Arms (2)

active treatment

EXPERIMENTAL

intermittent theta burst stimulation

Device: intermittend theta burst stimulation (iTBS)

waiting list

NO INTERVENTION

patients waiting for intervention

Interventions

intermittend theta burst stimulation (iTBS) DEVICE

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

Also known as: repetitive transcranial magnetic stimulation

active treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uni- or bipolar depression according to ICD-10
• present episode at least four weeks
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Berthold Langguth, Prof.

  University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 17, 2023
• Study Start: February 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)