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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014