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The recently completed one-year, double blind, placebo controlled trial had 235 patients from 21 participating hospitals in the United States, and showed clinically significant improvements due to treatment compared to baseline (note 2). Researchers decided to design a study specifically to measure changes in a patient's mood and depression due to stimulation of the vagus nerve The Omen Machine (Sword of Truth, Book 12). This first study found that there was indeed an improvement in mood for depressed patients. The long-term phase of the study lasted an additional 9 months (for one year total treatment) of stimulation. So far over 22,000 people worldwide have had VNS therapy (note 3), and it has proven to be a safe and effective treatment for epilepsy. The Omen Machine (Sword of Truth, Book 12) - The acute (short-term) phase lasted three months, during which half of the patients received stimulation (treatment group) and half did not (control group). The Omen Machine (Sword of Truth, Book 12) - In 1999, scientists began the first open label (no placebo group) study for depression with 60 patients. Based on this study, a more detailed and thorough study was designed to determine if Vagus Nerve Stimulation would be a safe, tolerable and effective treatment for chronic depression. The Omen Machine (Sword of Truth, Book 12) - When Vagus Nerve Stimulation was first approved for epilepsy, some patients reported an improvement in mood. The efficacy of the treatment has also been shown to increase with longer treatment time (note 1). The HRSD-24 (24 item clinician-rated Hamilton Rating Scale for Depression) improvements observed over the first year were highly significant. The Omen Machine (Sword of Truth, Book 12) - These patients have reported minimal side effects, which have tended to decrease over time.

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