NCT05732311

Brief Summary

This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

February 7, 2023

Last Update Submit

November 28, 2025

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • relapse (number of patients who have a relapse for depression)

    50% increase of symptoms according to Hamilton depression rating scale

    33 weeks

Secondary Outcomes (7)

  • Hamilton Depression Rating Scale

    49 weeks

  • Major Depression Inventory

    49 weeks

  • World Health Organisation quality of life bref

    49 weeks

  • clinical global impression

    49 weeks

  • Columbia-Suicide Severity Rating Scale

    49 weeks

  • +2 more secondary outcomes

Study Arms (2)

active treatment

EXPERIMENTAL

600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)

Device: intermittend theta burst stimulation

active treatment 2

ACTIVE COMPARATOR

600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)

Device: intermittend theta burst stimulation

Interventions

intermittend theta burst stimulationDEVICE

intermittend theta burst stimulation

active treatmentactive treatment 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
  • moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 \>16 points)
  • response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment \<11 points)
  • no concomitant psychotic symptoms.
  • no other relevant psychiatric disorder as assessed by the study physician
  • residence in Germany and German speaking that allows understanding of the information provided
  • patient is capable of giving consent

You may not qualify if:

  • fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
  • severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
  • current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
  • acute suicidality
  • pregnancy
  • current participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Berthold Langguth, Prof.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Schecklmann, Prof.

CONTACT

+49-941-941-2054martin.schecklmann@medbo.de

Mohamed Abdelnaim, Dr.

CONTACT

+49-941-941-1256mohamed.abdelnaim@medbo.de

Study Design

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

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 17, 2023

Study Start

April 25, 2023

Primary Completion

January 31, 2026

Study Completion

February 28, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)