Evaluation of Low Emission Neosync EEG Synchronized TMS Technology for the Treatment of Major Depressive Disorder: A Multicenter Randomized, Double-Blind, Sham-Controlled Trial
ID Number 11-0820Principal Investigator(s)
Dan V. Iosifescu
Department(s) or Division(s)
The primary objective of this study is to establish the safety and effectiveness of synchronized TMS (sTMS) therapy in comparison to sham in subjects with major depressive disorder who are not receiving anti-depressant medications.
In this study, participants are randomized, to either the sTMS treatment group or to a sham group (placebo) to evaluate the safety and efficacy of sTMS in subjects with major depressive disorder. This is a multicenter study in which approximately 186 subjects will be treated 5 days per week for 6 weeks. A follow up evaluation will be conducted four weeks after sTMS treatment is complete (Week 10). After signing informed consent, subjects who qualify for enrollment will discontinue use of their current antidepressant treatment (if applicable). Subjects must have discontinued the antidepressant medication a minimum of 1 week prior to initiation of treatment with the sTMS or sham device. Following wash-out of the antidepressant medication, an additional evaluation will be performed to determine whether the protocol eligibility criteria are met before randomization and treatment. Qualified subjects will be randomized to either sTMS or sham treatment groups. Treatment will be initiated on Day 1 of the study. Subjects will come to the clinic for 5 daily treatment sessions for a total of 6 "treatment" weeks. A visit interval of 5-10 calendar days has been set for each "treatment" week. Treatment will be discontinued at the end of Week 6 (30 treatment sessions). Subjects will be clinically evaluated for safety and efficacy at the end of each of the six weekly treatment courses. At the end of Week 6, subjects will have completed the study treatments and will be offered alternate antidepressant treatment as clinically indicated. Subjects will be asked to return for one follow up visit four weeks after their last sTMS treatment (Week 10) for evaluation and study completion.
Recruiting Patients: Yes