Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2025-07-31

Brief Summary

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This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The usage of a special active/placebo (A/P) coil in combination with an electrical co-stimulation will guarantee masking.

A hard cover surrounds the A/P coil and for this reason it is not possible to see which side is the active side of the coil. By entering a randomized code into the stimulator, the operator receive information whether the coil is in the correct position or has to be flipped around. The code does not allow third parties to identify to which study arm a patient has been assigned. The concealment of the assignment remains until the statistical analysis is finished.

Study Groups

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combined iTBS/cTBS

Combined theta burst stimulation (TBS) of the left (intermittent TBS, iTBS) and right (continuous TBS, cTBS) dorsolateral prefrontal cortex (dlPFC; F3 and F4 according to EEG10/20 system). Each stimulation session will comprise 2 trains of 600 stimuli each applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s. In the same session, stimulation with cTBS will be applied continuously for 40 s. Intensity of iTBS/cTBS will be standardized at 80 % of the resting motor threshold (rMT).

Additionally, patients receive an electrical co-stimulation of the forehead. One electrode is fixed to FZ and the 2nd one is either fixed to the left forehead (iTBS) or the right forehead (cTBS), rectangular aligned to the upper edge of the FZ-electrode with a distance of 0.5 cm. Intensity of the co-stimulation is applied with 50% of TBS-intensity.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

MagVenture Coil Cool B70 A/P

sham stimulation

Setup is identical to combined active iTBS/cTBS but TBS is not actively delivered

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

MagVenture Coil Cool B70 A/P without TMS being actively delivered

Interventions

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Transcranial Magnetic Stimulation

MagVenture Coil Cool B70 A/P

Intervention Type DEVICE

Sham Transcranial Magnetic Stimulation

MagVenture Coil Cool B70 A/P without TMS being actively delivered

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* moderate or severe unipolar depression diagnosed according to criteria of Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
* duration of the current episode must be ≥ 6 weeks and ≤ 2 years
* HDRS17 ≥ 18
* mild to moderate treatment resistance according to the Antidepressant Treatment History Form \[ATHF-SF\]. Treatment resistance is defined as having failed at least one but no more than three adequate antidepressant treatments in this episode
* stable antidepressive medication 4 weeks before treatment or no antidepressive treatment
* no further relevant psychiatric axis-I and/or axis-II disorder except for anxiety disorders (according to DSM-5 and SCID-5-PD)
* no comorbid psychotic symptoms
* ability to give consent

Exclusion Criteria

* acute suicidality (MADRS item 10 score \> 4)
* antiepileptic drugs and/or benzodiazepines corresponding to \> 1mg lorazepam / day
* history of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder
* history of seizures
* previous rTMS treatment
* lifetime history of non-response to adequate electroconvulsive therapy (minimum of eight treatments)
* deep brain stimulation
* cardiac pacemakers, intracranial implant, or metal in the cranium
* substance dependence or abuse in the past 3 months (with the exception of tobacco)
* severe somatic comorbidity as judged by the study physician
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No