Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03257397 |
Date of registration:
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18/08/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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TBS in Major Depression
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Scientific title:
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Theta-burst Transcranial Magnetic Stimulation for the Treatment of Major Depression |
Date of first enrolment:
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August 1, 2017 |
Target sample size:
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80 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03257397 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Georg S Kranz, PhD |
Address:
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Telephone:
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+43 1 40400 |
Email:
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georg.kranz@meduniwien.ac.at |
Affiliation:
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Name:
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Rupert Lanzenberger, A/Prof. |
Address:
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Telephone:
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+43 40400 |
Email:
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rupert.lanzenberger@meduniwien.ac.at |
Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Treatment Resistant Depression
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Intervention(s)
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Device: theta-burst stimulation (TBS) using a MagPro X1000
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Primary Outcome(s)
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HAMD
[Time Frame: <1 month]
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BDI-II
[Time Frame: <1 month]
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Secondary Outcome(s)
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Regional grey matter volume and using MRI
[Time Frame: <1 month]
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Regional white matter microstructure using DWI
[Time Frame: <1 month]
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Secondary ID(s)
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PSY-NIL-0008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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