NeuroStar TMS Therapy® Randomized Controlled Trial1
Primary diagnosis: DSM-IV Major Depressive Disorder
- Unipolar type, non-psychotic
- Moderate to severe symptoms at baseline
- Approximately one-third of patients had a co-morbid anxiety disorder (OCD excluded)
Antidepressant Treatment History (Indicated Population)
- Average number of antidepressant medication trials in current episode = 4 (range: 1 to 23 attempts)
- Majority of treatment attempts were unable to achieve adequate dose (minimum labeled dose) and duration (at least 4 weeks) of treatment due to intolerance
- In the indicated patient population, all patients failed to achieve satisfactory benefit from one antidepressant medication at an adequate dose and duration in the current episode
NeuroStar Randomized Controlled Trial Key Outcome Measure (Indicated Population) – Change Score in Montgomery Asberg Depression Rating Scale (MADRS)
In this controlled clinical trial, patients received an average reduction in their depression symptom score of 22.1% with active NeuroStar TMS Therapy as compared to a 9% average reduction in patients receiving inactive (sham) treatment. Statistical significance in favor of active NeuroStar TMS was observed as early as 2 weeks after treatment and at 4 and 6 weeks.
Treatment Utilization and Outcomes Study2
Patient Population & Sites
- 307 (acute phase) evaluable unipolar, non-psychotic MDD patients in post-market use
- 42 sites comprised of institutions and private practice
- 2 years for entire study
- Acute course as prescribed
- 12 month follow-up
The results of the open-label Outcomes study are consistent with prior open-label outcomes for NeuroStar TMS Therapy, in which 1 in 2 patients suffering with depression improved significantly, and 1 in 3 patients were completely free of depression symptoms after six weeks of treatment.3
- O’Reardon, J. P., H. B. Solvason, et al. (2007). “Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial.” Biol Psychiatry 62(11): 1208-1216.
- Neuronetics, Inc. (data on file, 2012)
- Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharm Bull. 2009, 42(2): 5-38.
*NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. Click here for full prescribing and safety information.