Antidepressant Effect of Theta-Burst rTMS

Rambam Health Care Campus

Status and phase: Unknown; Phase 2

Conditions: Major Depression

Treatments: Device: theta-burst rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT00515658

Rambam2141_CTIL

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)