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

Phase 2

Completed

• Conditions: Major Depression
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

• Registration Number: NCT01153139
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2012-12
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-13
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral theta burst stimulation to the DLPFC	Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)	intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC
Sham stimulation	Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)	Sham stimulation with a 45° tilted coil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change of the Hamilton rating scale for depression (HAMD 17)	baseline, after the end of treatment (week 6)
Change of the Beck Depression Inventory (BDI)	baseline, after the end of treatment (week 6)
Change of the Montgomery-Asberg rating scale for depression (MADRS) score	baseline, after the end of treatment (week 6)

Trial Locations

Locations (1)

University of Tübingen, Department of Psychiatry and Psychotherapy; 🇩🇪 Tübingen, Germany