Notes to editors
MDD Phase 2 Trial Design
This Phase 2 trial (SPD489-203) was a multicenter, randomized, double-blind parallel-group, placebo-controlled signal finding study designed to evaluate the safety and efficacy of Vyvanse in the treatment of adult patients aged 18-55 with Major Depressive Disorder (MDD) as an adjunctive therapy to anti-depressant therapy in patients experiencing residual symptoms of depression following treatment with LEXAPRO (escitalopram) monotherapy. The study enrolled approximately 246 patients at 15 study centers across the U.S. Of these, 239 subjects were treated with escitalopram monotherapy for up to 8 weeks (20 mg per day), 177 subjects were randomized (HAM-D17 greater than or equal to 4) and 129 of the 177 subjects met non-remission criteria (MADRS >10), among which 86 subjects achieved < 50% improvement in total MADRS score. These 129 non-remitting subjects were randomized in a double-blind design to adjunctive treatment with placebo or Vyvanse in addition to escitalopram. Blinded Vyvanse dosing was optimized over the range of 20 to 50 mg, based on clinical criteria. The primary efficacy analysis was the comparison of placebo and VYVANSE on the mean change in total MADRS score after 6 weeks of double-blind treatment. Regular safety assessments examining adverse events, vital signs, and electrocardiographic and laboratory parameters were also performed. Subjects were excluded from the trial if they had a history of ADHD diagnosis, ADHD symptoms, or treatment with ADHD medication. Subjects who were considered a suicide risk were also excluded.
About Major Depressive Disorder (MDD) and Inadequate Response in MDD
Major Depressive Disorder (MDD), also known as major depression, is a
mental disorder that causes depressed mood, loss of interest or pleasure,
feelings of guilt or low self-worth, disturbed sleep or appetite, low energy,
and poor conc
|SOURCE Shire plc|
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