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

July 13, 2013 updated by: Christian Plewnia, MD, University Hospital Tuebingen

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany
        • University of Tübingen, Department of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bilateral theta burst stimulation to the DLPFC
intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
Device: 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)
Placebo Comparator: Sham stimulation
Sham stimulation with a 45° tilted coil
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
after the end of treatment (week 6)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the Hamilton rating scale for depression (HAMD 17)
Time Frame: baseline, after the end of treatment (week 6)
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)
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)
baseline, after the end of treatment (week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 13, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124/2009BO1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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