This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. The FDA cleared BrainsWay D treatment of Major Depression in patients who failed to respond to one or more anti-depressants in the current episode.
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.