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Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression (TheBuS_D)

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • major Depression
  • informed consent

Exclusion Criteria:

  • seizures in medical history
  • metallic implants
  • deep brain stimulation
  • cardiac pacemaker
  • brain trauma
  • psychotic symptoms
  • substance abuse
  • pregnancy
  • Benzodiazepines other than Lorazepam >1mg/d

Sites / Locations

  • University of Tübingen, Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bilateral theta burst stimulation to the DLPFC

Sham stimulation

Arm Description

intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC

Sham stimulation with a 45° tilted coil

Outcomes

Primary Outcome Measures

Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)

Secondary Outcome Measures

Change of the Hamilton rating scale for depression (HAMD 17)
Change of the Beck Depression Inventory (BDI)
Change of the Montgomery-Asberg rating scale for depression (MADRS) score

Full Information

First Posted
April 23, 2010
Last Updated
July 13, 2013
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01153139
Brief Title
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
Acronym
TheBuS_D
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilateral theta burst stimulation to the DLPFC
Arm Type
Experimental
Arm Description
intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
Arm Title
Sham stimulation
Arm Type
Placebo Comparator
Arm Description
Sham stimulation with a 45° tilted coil
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
Intervention Description
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)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Change of the Hamilton rating scale for depression (HAMD 17)
Time Frame
baseline, after the end of treatment (week 6)
Title
Change of the Beck Depression Inventory (BDI)
Time Frame
baseline, after the end of treatment (week 6)
Title
Change of the Montgomery-Asberg rating scale for depression (MADRS) score
Time Frame
baseline, after the end of treatment (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: major Depression informed consent Exclusion Criteria: seizures in medical history metallic implants deep brain stimulation cardiac pacemaker brain trauma psychotic symptoms substance abuse pregnancy Benzodiazepines other than Lorazepam >1mg/d
Facility Information:
Facility Name
University of Tübingen, Department of Psychiatry and Psychotherapy
City
Tübingen
Country
Germany

12. IPD Sharing Statement

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Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression

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