Major DepressionPhase 2/3TheBuS_DNCT01153139
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) in people with Major Depression, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Jul 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- major Depression
- informed consent
Who cannot join
- seizures in medical history
- metallic implants
- deep brain stimulation
- cardiac pacemaker
- brain trauma
- psychotic symptoms
Show all 9Show fewer
- substance abuse
- pregnancy
- Benzodiazepines other than Lorazepam >1mg/d
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen
About this study
Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.
This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.
- Conditions
- Major Depression
- Being tested
- Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
- Keywords
- Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)Device
intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)
| Study group | Role | What they receive |
|---|---|---|
| bilateral theta burst stimulation to the DLPFC | Experimental | intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC Receives: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) |
| Sham stimulation | Placebo comparator | Sham stimulation with a 45° tilted coil Receives: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
Measured: after the end of treatment (week 6)
Secondary outcomes (3)
Change of the Hamilton rating scale for depression (HAMD 17)
Measured: baseline, after the end of treatment (week 6)
Change of the Beck Depression Inventory (BDI)
Measured: baseline, after the end of treatment (week 6)
Change of the Montgomery-Asberg rating scale for depression (MADRS) score
Measured: baseline, after the end of treatment (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153139
- Sponsor's protocol ID
- 124/2009BO1
- Acronym
- TheBuS_D
- Status last verified
- Jul 2013
- First submitted
- 23 Apr 2010
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT01153139
- Acronym / sponsor ID
- TheBuS_D / 124/2009BO1
- Conditions
- Major Depression
- Keywords
- Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- 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.
Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.
This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral theta burst stimulation to the DLPFC | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC |
| Sham stimulation | Placebo comparator | Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)Sham stimulation with a 45° tilted coil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major Depression
- informed consent
Key exclusion criteria (9 listed)
- seizures in medical history
- metallic implants
- deep brain stimulation
- cardiac pacemaker
- brain trauma
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold) | Device | Sham stimulation, bilateral theta burst stimulation to the DLPFC |
Primary outcome
Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
Time frame: after the end of treatment (week 6)
3 secondary outcomes
Change of the Hamilton rating scale for depression (HAMD 17)
Time frame: baseline, after the end of treatment (week 6)
Change of the Beck Depression Inventory (BDI)
Time frame: baseline, after the end of treatment (week 6)
Change of the Montgomery-Asberg rating scale for depression (MADRS) score
Time frame: baseline, after the end of treatment (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) in people with Major Depression, run by University Hospital Tuebingen 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%) (time frame: after the end of treatment (week 6)). 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 16 Jul 2013.