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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01153139
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Change of the Hamilton rating scale for depression (HAMD 17) [baseline, after the end of treatment (week 6)]

2. Change of the Beck Depression Inventory (BDI) [baseline, after the end of treatment (week 6)]

3. Change of the Montgomery-Asberg rating scale for depression (MADRS) score [baseline, after the end of treatment (week 6)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Tübingen, Department of Psychiatry and Psychotherapy	Tübingen		Germany

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian Plewnia, MD, Prof. Dr. med., University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT01153139
• Other Study ID Numbers: 124/2009BO1
• First Posted: Jun 29, 2010
• Last Update Posted: Jul 16, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Christian Plewnia, MD, Prof. Dr. med., University Hospital Tuebingen: Transcranial Magnetic Stimulation; Depression; Theta Burst Stimulation
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of Jul 16, 2013