Major Depression Clinical Trial
Official title:
Antidepressant Effect of Theta-Burst rTMS
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.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Medical Center | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
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