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

Major Depression Clinical Trial

— TheBuS_D  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153139
• Other study ID #: 124/2009BO1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 23, 2010
• Last updated: July 13, 2013
• Start date: April 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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)

Locations

Country	Name	City	State
Germany	University of Tübingen, Department of Psychiatry and Psychotherapy	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)		after the end of treatment (week 6)	No
Secondary	Change of the Hamilton rating scale for depression (HAMD 17)		baseline, after the end of treatment (week 6)	Yes
Secondary	Change of the Beck Depression Inventory (BDI)		baseline, after the end of treatment (week 6)	No
Secondary	Change of the Montgomery-Asberg rating scale for depression (MADRS) score		baseline, after the end of treatment (week 6)	No