Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
NCT ID: NCT01153139
Last Updated: 2013-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2010-04-30
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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bilateral theta burst stimulation to the DLPFC
intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
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)
Sham stimulation
Sham stimulation with a 45° tilted coil
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* informed consent
Exclusion Criteria
* metallic implants
* deep brain stimulation
* cardiac pacemaker
* brain trauma
* psychotic symptoms
* substance abuse
* pregnancy
* Benzodiazepines other than Lorazepam \>1mg/d
18 Years
70 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Christian Plewnia, MD
Prof. Dr. med.
Locations
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University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, , Germany
Countries
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Other Identifiers
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124/2009BO1
Identifier Type: -
Identifier Source: org_study_id
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