DepressionPROTECTNCT05732311
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
A study testing intermittend theta burst stimulation in people with Depression, run by Berthold Langguth, MD, Ph.D. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- intermittend theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055
Berthold Langguth, +49-941-941-2099, berthold.langguth@medbo.de
About this study
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.
- Conditions
- Depression
- Being tested
- intermittend theta burst stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittend theta burst stimulationDevice
intermittend theta burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: intermittend theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse (number of patients who have a relapse for depression)
50% increase of symptoms according to Hamilton depression rating scale
Measured: 33 weeks
Secondary outcomes (7)
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Measured: 49 weeks
Major Depression Inventory
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Measured: 49 weeks
World Health Organisation quality of life bref
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Measured: 49 weeks
clinical global impression
clinical global impression (range: 0-7; higher values = worse outcome)
Measured: 49 weeks
Columbia-Suicide Severity Rating Scale
Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)
Measured: 49 weeks
Beck Anxiety Index
Beck Anxiety Index (range: 0-63; higher values = worse outcome)
Measured: 49 weeks
Global Assessment of Functioning
Global Assessment of Functioning (range: 0-100; lower values = worse outcome)
Measured: 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start25 Apr 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berthold Langguth, MD, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, Prof., Principal investigator, University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732311
- Sponsor's protocol ID
- 22-3167-101
- Acronym
- PROTECT
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2023
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
- ClinicalTrials.gov ID
- NCT05732311
- Acronym / sponsor ID
- PROTECT / 22-3167-101
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Berthold Langguth, MD, Ph.D.University, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active treatment | Experimental | Device: intermittend theta burst stimulation600 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) |
| active treatment 2 | Active comparator | Device: intermittend theta burst stimulation600 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittend theta burst stimulationintermittend theta burst stimulation | Device | active treatment, active treatment 2 |
Primary outcome
relapse (number of patients who have a relapse for depression)
Time frame: 33 weeks
50% increase of symptoms according to Hamilton depression rating scale
7 secondary outcomes
Hamilton Depression Rating Scale
Time frame: 49 weeks
Major Depression Inventory
Time frame: 49 weeks
World Health Organisation quality of life bref
Time frame: 49 weeks
clinical global impression
Time frame: 49 weeks
Columbia-Suicide Severity Rating Scale
Time frame: 49 weeks
Beck Anxiety Index
Time frame: 49 weeks
Global Assessment of Functioning
Time frame: 49 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berthold Langguth, Prof. principal investigator
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittend theta burst stimulation in people with Depression, run by Berthold Langguth, MD, Ph.D. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Schecklmann, Prof. (+49-941-941-2054, martin.schecklmann@medbo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse (number of patients who have a relapse for depression) (time frame: 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.