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Antidepressant Effect of Theta-Burst rTMS

Phase 2
Conditions
Major Depression
Registration Number
NCT00515658
Lead Sponsor
Rambam Health Care Campus
Brief Summary

The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients with major depression. Patients will be randomized to receive ether left-sided intermittent theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two weeks period with an option for an additional two weeks period, depending on treatment response. Clinical assessments will be performed weekly by the Hamilton depression rating scale. In addition, standard neurophysiological assessment of cortical excitability will be done.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Major depressive episode (DSM IV criteria).
  • Informed consent.
  • Age: 18-70.
Exclusion Criteria
  • Suicidality
  • Psychosis
  • Pacemaker
  • Cardiac arrythmia
  • seizure disorder
  • implantable metal devices
  • PNS and CNS disorders
  • any other contraindications as specified in safety guidelines for rTMS (Wassermenn, 1998).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rambam Medical Center

🇮🇱

Haifa, Israel

Rambam Medical Center
🇮🇱Haifa, Israel
Ehud Klein, MD
Principal Investigator
Andrei Chistyakov, PhD
Sub Investigator
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