DepressionTRUSTNCT05732298
Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment
A study testing intermittend theta burst stimulation (iTBS) in people with Depression, run by University of Regensburg at 1 site in Germany.
Trial 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). 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 (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 27 Feb 2023to 31 Mar 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
- uni- or bipolar depression according to ICD-10
- present episode at least four weeks
- 18-70 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
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).
Read more
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
- Being tested
- intermittend theta burst stimulation (iTBS)
- 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 stimulation (iTBS)Device
Also called repetitive transcranial magnetic stimulation
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday
| Study group | Role | What they receive |
|---|---|---|
| active treatment | Experimental | intermittent theta burst stimulation Receives: Device: intermittend theta burst stimulation (iTBS) |
| waiting list | No intervention | patients waiting for intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Measured: 8 weeks
Secondary outcomes (5)
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Measured: 20 weeks
Major Depression Inventory
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Measured: 20 weeks
World Health Organisation quality of life bref
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Measured: 20 weeks
State Trait Anxiety Inventory
State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome)
Measured: 20 weeks
clinical global impression
clinical global impression (range: 0-7; higher values = worse outcome)
Measured: 20 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 start27 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT05732298
- Sponsor's protocol ID
- 22-3053-101
- Acronym
- TRUST
- 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
- Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
- ClinicalTrials.gov ID
- NCT05732298
- Acronym / sponsor ID
- TRUST / 22-3053-101
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 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, 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.
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 stimulation (iTBS)intermittent theta burst stimulation |
| waiting list | No intervention | –patients waiting for intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- uni- or bipolar depression according to ICD-10
- present episode at least four weeks
- 18-70 years old
- no intake and rejection of anti-depressant medication and
- no adequate anti-depressant medication in the present episode
Key exclusion criteria (6 listed)
- 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
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 stimulation (iTBS)Also: repetitive transcranial magnetic stimulation600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday | Device | active treatment |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 8 weeks
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
5 secondary outcomes
Hamilton Depression Rating Scale
Time frame: 20 weeks
Major Depression Inventory
Time frame: 20 weeks
World Health Organisation quality of life bref
Time frame: 20 weeks
State Trait Anxiety Inventory
Time frame: 20 weeks
clinical global impression
Time frame: 20 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
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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. This study is not recruiting at the moment.
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 (iTBS) in people with Depression, run by University of Regensburg 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: 8 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.