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NCT Number: NCT05732311

Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

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.

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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, University of Regensburg

Regensburg, 93055, Germany

Location status: Recruiting

Location contact

Berthold Langguth

CONTACT

[email protected]

+49-941-941-2099

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

intermittend theta burst stimulation

Device

intermittend theta burst stimulation

Primary outcomes

  1. relapse (number of patients who have a relapse for depression)

    Time frame: 33 weeks

    50% increase of symptoms according to Hamilton depression rating scale

Secondary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 49 weeks

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

  2. Major Depression Inventory

    Time frame: 49 weeks

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

  3. World Health Organisation quality of life bref

    Time frame: 49 weeks

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

  4. clinical global impression

    Time frame: 49 weeks

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

  5. Columbia-Suicide Severity Rating Scale

    Time frame: 49 weeks

    Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)

  6. Beck Anxiety Index

    Time frame: 49 weeks

    Beck Anxiety Index (range: 0-63; higher values = worse outcome)

  7. Global Assessment of Functioning

    Time frame: 49 weeks

    Global Assessment of Functioning (range: 0-100; lower values = worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Schecklmann, Prof.

CONTACT

[email protected]

+49-941-941-2054

Mohamed Abdelnaim, Dr.

CONTACT

[email protected]

+49-941-941-1256

Sponsors and collaborators

Lead sponsor

Berthold Langguth, MD, Ph.D.

Other

Registry information

Acronym: PROTECT

Important dates

Study start
2023
Primary completion
2026
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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