This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Shalvata Mental Health Center, Hod-Hasharon, Israel
13 January, 2009
A double-blinded and placebo-controlled clinical trial has begun at the Shalvata Mental Health Center to explore the efficacy and safety of Braisnway® Deep TMS in 50 subjects with bipolar depression, currently treated with mood stabilizers and previously unsuccessfully treated with antidepressant medication.
The trial is expected to be carried out over the course of 7 weeks in respect of each subject.
This trial is expected to serve as the basis for a broad multi-center trial.