A noninvasive transcranial magnetic stimulation device improves symptoms and quality of life in patients with moderate-to-severe depression who have an inadequate response to antidepressant medication, according to a presentation at the annual meeting of the American Psychiatric Association.

"Symptom control is only meaningful in so far as it improves patients' ability to function and enjoy life, which is an essential part of the recovery process," said H. Brent Solvason, MD, PhD, Assistant Professor of Psychiatry at Stanford University. Dr. Solvason was a primary investigator in the NeuroStar TMS Therapy(TM) studies and is the lead author of this data report. "Ideally, the combination of both symptomatic and functional improvement should be the goal of treatment."

At baseline, the study population (N = 301) had significant symptomatic and functional impairment related to depression. After 4 weeks of treatment, 155 patients who received active therapy had statistically significant improvements in General Health and Mental Health subscales, as well as the Mental Component Score, of the SF-36 health outcomes measure.

After 6 weeks, significant improvements were also seen in the SF-36 Role-Emotional subscale and the Quality of Life Enjoyment and Satisfaction Questionnaire--Q-LES-Q, a common measurement tool used to assess quality of life in patients suffering from depression. The effect sizes observed in functional status improvement were similar in magnitude to the effect sizes observed in symptomatic benefit.

"These data demonstrate that NeuroStar TMS Therapy produced significant improvements in depressive symptoms that were accompanied by concurrent improvements in patient-reported functional status and quality of life," said Solvason.

A second trial evaluated the acute efficacy of therapy in an open-label setting, which more closely resembles real-world clinical practice. In this study, therapy was administered as monotherapy in 158 patients for a 6-week period. At the end of 6 weeks, there was a three-week taper phase, which included co-administration of medication monotherapy.

Patients experienced a significant improvement in symptoms, from baseline, as early as Week 2. Actively treated patients also achieved a 42 percent response rate and a 27 percent remission rate at the end of 6 weeks as measured by the 24-item Hamilton Depression Rating Scale (HAMD-24).

At the end of the taper phase, the response rate increased to 46 percent and the remission rate increased to 37 percent. The response rate was defined as the percentage of patients who experienced at least a 50 percent improvement in symptoms.

"The clinical significance of the treatment benefit is demonstrated by the substantial proportion of patients who achieved both response and the more stringent outcome of remission," said Mark A. Demitrack, MD, Chief Medical Officer for Neuronetics, a psychiatrist, and an author of the study. "The clinical significance of these data can also be demonstrated by comparison with the recently reported outcomes from the large, open-label STAR*D treatment study. Remission rates with NeuroStar TMS Therapy observed in this study met or exceeded those reported for STAR*D when patients were stratified by level of prior treatment failure."

The transcranial magnetic stimulation system is an investigational medical device studied clinically for treatment of depression. It is administered as an outpatient procedure, does not require anesthesia or sedation, and can be performed in a psychiatrist's office. It works by delivering highly focused magnetic resonance imaging-strength magnetic field pulses that stimulate neurons linked to mood and major depressive disorder.