Clinical trials have proven the efficacy and safety of NeuroStar TMS Therapy in treating patients with depression who have not benefitted from prior antidepressant medications. NeuroStar TMS Therapy was studied in adult patients suffering from unipolar, non-psychotic Major Depressive Disorder. All of these patients had achieved little to no success with previous antidepressant medication.

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.

In clinical trials, the indiciated population had been treated with at least four medication treatment attempts, one of which was at an adequate dose and duration.

NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Efficacy has not been established in patients who have failed to receive benefit from two or more prior antidepressant medications at minimal effective dose and duration in the current episode.

An Effective Option for Treating Major Depressive Disorder

Demonstrated Acute MDD Efficacy in Randomized, Controlled Trial¹

• 164 patients from indicated patient population
• Triple-blinded (treater, rater, and patient)
• 4-6 weeks of TMS monotherapy

Patients treated with active NeuroStar TMS Therapy^® experienced an average reduction in their depression symptoms of 22.1% compared to a 9% average reduction of depression symptoms in patients receiving inactive treatment (Sham).

NeuroStar^®-treated patients also experienced significant improvement in anxiety other symptoms associated with depression such as appetite changes, aches and pains, and lack of energy.²

Acute MDD Efficacy Results in Open-Label Clinical Trial^2,3

• 43 patients from indicated patient population
• 6 weeks of TMS monotherapy

Approximately half of the patients treated with NeuroStar TMS Therapy^® experienced significant improvement in depression symptoms. About a third of the patients treated with NeuroStar TMS Therapy^® experienced complete symptom relief at the end of six weeks.

Demonstrated Safety and Tolerability

Treatment with NeuroStar TMS Therapy caused few side effects and was generally well tolerated by patients. The most common side effects reported during clinical trials were headache and scalp pain or discomfort — which were generally mild to moderate and occurred less frequently after the first week of treatment.

Less than 5% of patients discontinued treatment with NeuroStar TMS Therapy due to adverse events through the primary study endpoint (4 weeks).

Over 10,000 active treatments were performed across all NeuroStar clinical trials demonstrating its safety⁴

• No seizures
• No systemic side effects
• No weight gain
• No sexual dysfunction
• No sedation
• No nausea
• No dry mouth
• No adverse effects on concentration or memory
• No device-drug interactions

There is a low risk of seizure with TMS Therapy. The estimated risk of seizure under ordinary clinical use is approximately 1 in 30,000 treatments (0.003% of treatments) or 1 in 1000 patients (0.1% of patients).

Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.

NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices or non-removable metallic objects in or around the head. Patients with braces and metal fillings are acceptable for treatment; however, patients with other metal within their mouth should discuss this with their physician.

NeuroStar TMS Therapy should be used with caution in patients with implants controlled by physiological signals. This includes pacemakers and implantable cardioverter defibrillators (ICDs).

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References:

1. Lisanby S, et al. Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Treatment of Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial. Neuropsychopharmacology, advance online publication, 13 August 2009, doi:10.1.038/npp.2008.118.
2. Data on file.
3. Demitrack MA, Thase ME, Clinical Significance of Transcranial Magnetic Stimulation in the treatment of depression: Synthesis of Recent Data. Psychopharmacology Bulletin 2009; 42(2):5-38.
4. Janicak P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry, 2008; Vol 69:222-232.