Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression (PROTECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: intermittend theta burst stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Schecklmann, Prof.; Phone Number: +49-941-941-2054; Email: martin.schecklmann@medbo.de
• Study Contact Backup: Name: Mohamed Abdelnaim, Dr.; Phone Number: +49-941-941-1256; Email: mohamed.abdelnaim@medbo.de

Study Locations

• Germany
  • Regensburg, Germany, 93055
    • Recruiting
    • Department of Psychiatry and Psychotherapy, University of Regensburg
    • Contact: Berthold Langguth; Phone Number: +49-941-941-2099; Email: berthold.langguth@medbo.de

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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; 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; intermittend theta burst stimulation
Active Comparator: active treatment 2; 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; intermittend theta burst stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse (number of patients who have a relapse for depression)	50% increase of symptoms according to Hamilton depression rating scale	33 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)	49 weeks
Major Depression Inventory	Major Depression Inventory (range: 0-50; higher values = worse outcome)	49 weeks
World Health Organisation quality of life bref	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)	49 weeks
clinical global impression	clinical global impression (range: 0-7; higher values = worse outcome)	49 weeks
Columbia-Suicide Severity Rating Scale	Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)	49 weeks
Beck Anxiety Index	Beck Anxiety Index (range: 0-63; higher values = worse outcome)	49 weeks
Global Assessment of Functioning	Global Assessment of Functioning (range: 0-100; lower values = worse outcome)	49 weeks

Collaborators and Investigators

• Sponsor: Berthold Langguth, MD, Ph.D.
• 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): April 25, 2023
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): February 28, 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
• Other Study ID Numbers: 22-3167-101

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