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TBS in Major Depression

Primary Purpose

Treatment Resistant Depression

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
theta-burst stimulation (TBS) using a MagPro X1000
theta-burst stimulation (TBS) using a MagPro X1000
Sponsored by
Rupert Lanzenberger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-5 diagnosis of a single or recurrent major depression
  • Failure of at least two adequate antidepressant treatments
  • HAMD-17 total score of ≥ 23 and a Clinical Global Impression Scale (CGI-S) of ≥ 4
  • Stable psychopharmacological treatment within 2 weeks prior inclusion
  • Age 18-65 years
  • Right-handedness (assessed with the Edinburgh Handedness Inventory)

Exclusion Criteria:

  • Seizures in medical history
  • Medical history of major systemic illness, neurological disorders and previous brain injuries
  • Ferromagnetic implants, cardiac pacemaker, deep brain stimulation and other common MRI and TMS exclusion criteria
  • Current psychotic symptoms
  • Substance abuse or dependence within last 3 months
  • Borderline personality disorder (based on DSM-5 criteria)
  • Pregnancy
  • Active suicidal intent
  • Benzodiazepines other than Lorazepam < 2mg/d
  • failure to comply with the study protocol or to follow the instructions of the investigating team

Sites / Locations

  • Department of Psychiatry and Psychotherapy, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

left iTBS and right cTBS

left and right iTBS

Arm Description

40 patients will receive intermittent theta-burst stimulation (iTBS) over the left dorsolateral prefrontal cortex (DLPFC) and continuous TBS (cTBS) over the right DLPFC

40 patients will receive intermittent theta-burst stimulation (iTBS) over the left and right dorsolateral prefrontal cortex (DLPFC)

Outcomes

Primary Outcome Measures

HAMD
Hamilton depression rating scale
BDI-II
Beck Depression Inventory

Secondary Outcome Measures

Regional white matter microstructure using DWI
White matter microstructure will be investigated using diffusion tensor imaging and analyzed using tract-based spatial statistics and tractography
Regional grey matter volume and using MRI
Regional grey matter volume will be investigated using voxel-based morphometry

Full Information

First Posted
August 18, 2017
Last Updated
March 11, 2019
Sponsor
Rupert Lanzenberger
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1. Study Identification

Unique Protocol Identification Number
NCT03257397
Brief Title
TBS in Major Depression
Official Title
Theta-burst Transcranial Magnetic Stimulation for the Treatment of Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rupert Lanzenberger

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background Major depression is associated with morbidity and increased mortality. Along with the psychological strain depression represents a high socioeconomic burden costing Europe more than €113 billion/year. About one third of patients do not respond to appropriate therapy. Theta-burst stimulation (TBS), a form of transcranial magnetic stimulation is an emerging treatment for patients for whom pharmacological treatment is ineffective or not appropriate. Based on two different theories of prefrontal dysfunction two TBS-protocols should have the most antidepressant effects. However, no study so far has compared the two approaches or systematically investigated their differential effects on brain function and on a symptom level. Objectives of the study The aim of this study is to test two TBS protocols on symptom improvement and associated brain function in patients with treatment resistant depression (TRD): iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC. As stimulation over non-motor regions offers no direct readout, fMRI at baseline and after treatment will be harnessed to quantify an effect on brain activity and functional network metrics. Study population 80 patients with TRD will be enrolled with 40 patients receiving the one, and 40 patients receiving the other TBS protocol for a treatment period of three weeks. Study design The study is designed as a longitudinal, randomized and double-blind clinical trial. At baseline and after treatment, patients will undergo psychiatric testing using several symptom scales including the Hamilton Depression Rating Scale (HAMD-17), the Beck Depression Inventory (BDI-II), the Inventory of Depressive Symptomatology (IDS-C) and the State-Trait Anxiety Inventory (STAI). Changes in HAMD-17 scores are defined as primary endpoint. Moreover MRI scans before and after treatment will include structural and functional MRI sequences as well as diffusion weighted imaging (DWI) sequence. Functional connectivity and BOLD responses will serve as primary imaging endpoints. A follow-up visit 2 weeks and a final examination 4 weeks after treatment will elucidate durability of effects. Relevance and implications of the study By investigating which approach is superior for which symptoms our study will contribute to the development of personalized treatment, the reduction of personal suffering and the reduction of costs and occupational disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
left iTBS and right cTBS
Arm Type
Experimental
Arm Description
40 patients will receive intermittent theta-burst stimulation (iTBS) over the left dorsolateral prefrontal cortex (DLPFC) and continuous TBS (cTBS) over the right DLPFC
Arm Title
left and right iTBS
Arm Type
Active Comparator
Arm Description
40 patients will receive intermittent theta-burst stimulation (iTBS) over the left and right dorsolateral prefrontal cortex (DLPFC)
Intervention Type
Device
Intervention Name(s)
theta-burst stimulation (TBS) using a MagPro X1000
Other Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
iTBS over left and cTBS over right dorsolateral prefrontal cortex for a period of three weeks. iTBS: 3-pulse 50 Hz bursts will be given every 200ms (at 5 Hz) in 2-second trains with an inter-train interval of 8 seconds. cTBS: 3-pulse 50 Hz bursts will be given every 200ms (at 5 Hz) in a single 40s train; one session will comprise left iTBS and right cTBS. There will be two sessions daily with 60 min in between sessions
Intervention Type
Device
Intervention Name(s)
theta-burst stimulation (TBS) using a MagPro X1000
Other Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
iTBS over left and right dorsolateral prefrontal cortex for a period of three weeks. iTBS consists of 3-pulse 50 Hz bursts which will be given every 200ms (at 5 Hz) in 2-second trains with an inter-train interval of 8 seconds. One session will comprise left and right iTBS. There will be two sessions daily with 60 min in between sessions
Primary Outcome Measure Information:
Title
HAMD
Description
Hamilton depression rating scale
Time Frame
<1 month
Title
BDI-II
Description
Beck Depression Inventory
Time Frame
<1 month
Secondary Outcome Measure Information:
Title
Regional white matter microstructure using DWI
Description
White matter microstructure will be investigated using diffusion tensor imaging and analyzed using tract-based spatial statistics and tractography
Time Frame
<1 month
Title
Regional grey matter volume and using MRI
Description
Regional grey matter volume will be investigated using voxel-based morphometry
Time Frame
<1 month
Other Pre-specified Outcome Measures:
Title
Global physical activity
Description
assessed using Clinical Global Impression Scale (CGI-S)
Time Frame
<1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-5 diagnosis of a single or recurrent major depression Failure of at least two adequate antidepressant treatments HAMD-17 total score of ≥ 23 and a Clinical Global Impression Scale (CGI-S) of ≥ 4 Stable psychopharmacological treatment within 2 weeks prior inclusion Age 18-65 years Right-handedness (assessed with the Edinburgh Handedness Inventory) Exclusion Criteria: Seizures in medical history Medical history of major systemic illness, neurological disorders and previous brain injuries Ferromagnetic implants, cardiac pacemaker, deep brain stimulation and other common MRI and TMS exclusion criteria Current psychotic symptoms Substance abuse or dependence within last 3 months Borderline personality disorder (based on DSM-5 criteria) Pregnancy Active suicidal intent Benzodiazepines other than Lorazepam < 2mg/d failure to comply with the study protocol or to follow the instructions of the investigating team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg S Kranz, PhD
Phone
+43 1 40400
Ext
38250
Email
georg.kranz@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Rupert Lanzenberger, Assoc.Prof
Phone
+43 1 40400
Ext
35760
Email
rupert.lanzenberger@meduniwien.ac.at
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupert Lanzenberger, A/Prof.
Phone
+43 40400
Ext
3825
Email
rupert.lanzenberger@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Rupert Lanzenberger, A/Prof. MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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