Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
TheBuS_D
1 other identifier
interventional
32
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 16, 2013
July 1, 2013
2.7 years
April 23, 2010
July 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
after the end of treatment (week 6)
Secondary Outcomes (3)
Change of the Hamilton rating scale for depression (HAMD 17)
baseline, after the end of treatment (week 6)
Change of the Beck Depression Inventory (BDI)
baseline, after the end of treatment (week 6)
Change of the Montgomery-Asberg rating scale for depression (MADRS) score
baseline, after the end of treatment (week 6)
Study Arms (2)
bilateral theta burst stimulation to the DLPFC
EXPERIMENTALintermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
Sham stimulation
PLACEBO COMPARATORSham stimulation with a 45° tilted coil
Interventions
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
You may qualify if:
- major Depression
- informed consent
You may not qualify if:
- seizures in medical history
- metallic implants
- deep brain stimulation
- cardiac pacemaker
- brain trauma
- psychotic symptoms
- substance abuse
- pregnancy
- Benzodiazepines other than Lorazepam \>1mg/d
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
April 23, 2010
First Posted
June 29, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
July 16, 2013
Record last verified: 2013-07