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May 2008
Evaluating Clinical Significance of Treatment Outcomes in Studies of
Resistant Major Depression
The researchers evaluated the results of two clinical trials involving
164 patients with unipolar non-psychotic major depressive disorder who
did not receive adequate benefit from one previous treatment at or above
the minimal effective dose and duration. The first trial was a
four-to-six week randomized, placebo-controlled, double-blind,
monotherapy study of Transcranial Magnetic Stimulation (TMS). Patients who did not respond to therapy in the first
study were entered into a second six-week, open-label TMS monotherapy trial.
The research was conducted to assess the effectiveness of the Neuronetics
NeuroStar TMS device to determine its effectiveness compared to placebo,
and target when it should be introduced.
The results indicated that TMS therapy was as effective or more effective
than the majority of approved pharmaceutical antidepressant treatments
for either treatment-responsive or-resistant populations. Patients who
failed to achieve improvement from major depressive disorder with one
prior antidepressant had the most improvement from TMS treatment.
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