Study Design and Methodology for a Multicenter, Randomized Controlled Trial of NeuroStar Transcranial Magnetic Stimulation in Adolescent Patients With Major Depressive Disorder
This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
NeuroStar Transcranial Magnetic Stimulation is a safe and effective non-invasive neuromodulation treatment for Major Depressive Disorder (MDD) in adults who have failed to benefit from prior antidepressant medication treatment. MDD is also a major health problem in adolescents; however, current treatment options frequently fail to provide adequate clinical improvement. TMS offers a potential alternative for adolescents with MDD but the safety and efficacy of TMS has not been established in this population. This trial is will be a large multicenter double-blind randomized controlled study in adolescent patients (12-21) with MDD. This study is designed with three phases: Phase I is the double blind randomized trial to evaluate the antidepressant effects 6 weeks of daily TMS in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode with patients randomized to active vs sham treatment. Phase II is an open label 6 week study for patients that did not meet criteria for clinical benefit in Phase I. Phase III is a 6 month, medication-free follow-up study with protocol defined re-introduction of TMS for symptom re-emergence. This phase is for any patients who in Phase I or II meet criteria for clinical benefit after treatment. This study is recruiting 100 evaluable patients across 13 study sites in the US. Treatment design will be discussed including but not limited to primary efficacy outcome, statistical plan using meta-analysis, TMS as a monotherapy, and recruitment and retention.