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NCT00515658 Clinical Trial

Antidepressant Effect of Theta-Burst rTMS

Major Depression Clinical Trial

Official title:
Antidepressant Effect of Theta-Burst rTMS

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00515658
Other study ID # Rambam2141_CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received August 13, 2007
Last updated August 13, 2007
Start date March 2007

Study information
Verified date August 2007
Source Rambam Health Care Campus
Contact Ehud Klein, MD
Phone 972-4-8543599
Email e_klein@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• theta-burst rTMS

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

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