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

University Hospital Tuebingen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depression

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01153139

124/2009BO1

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

bilateral theta burst stimulation to the DLPFC

Experimental group

Description:

intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

Sham stimulation

Placebo Comparator group

Description:

Sham stimulation with a 45° tilted coil

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)