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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Plewnia, MD, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01153139
First received: April 23, 2010
Last updated: July 13, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Major Depression
Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of the Hamilton rating scale for depression (HAMD 17) [ Time Frame: baseline, after the end of treatment (week 6) ] [ Designated as safety issue: Yes ]
  • Change of the Beck Depression Inventory (BDI) [ Time Frame: baseline, after the end of treatment (week 6) ] [ Designated as safety issue: No ]
  • Change of the Montgomery-Asberg rating scale for depression (MADRS) score [ Time Frame: baseline, after the end of treatment (week 6) ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153139

Locations
Germany
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, Germany
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: Christian Plewnia, MD, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01153139     History of Changes
Other Study ID Numbers: 124/2009BO1
Study First Received: April 23, 2010
Last Updated: July 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
Transcranial Magnetic Stimulation
Depression
Theta Burst Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014