Status:
UNKNOWN
TBS in Major Depression
Lead Sponsor:
Rupert Lanzenberger
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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 bi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03257397
Start Date
August 1 2017
End Date
December 31 2020
Last Update
March 13 2019
Active Locations (1)
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1
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria, 1090