Main Study: SPD489 Treatment of Adults with Major Depressive Disorder

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Double-blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant

• IRAS ID

  105246

• Contact name

  Reinhard Heun

• Sponsor organisation

  Shire Development LLC

• Eudract number

  2011-003615-28

• ISRCTN Number

  n/a

• Research summary

  Literature reports suggest that amphetamine-based pharmacological therapy is a viable option for the treatment of depression when used as adjunctive therapy (in combination with antidepressants) to treat residual depressive symptoms. This hypothesis has been supported by results from a recently completed Phase 2 study (SPD489-203) of the investigational drug SPD489 (lisdexamfetamine dimesylate). Lisdexamfetamine is classified as a psychomotor stimulant. The active metabolite, d amphetamine, exerts its pharmacological effects in the central nervous system - with one mode of action being to inhibit neuronal reuptake of norepinephrine and dopamine to prolong their concentration and time in the synaptic cleft. Initially, SPD489 capsules were developed for the once daily treatment of attention-deficit/hyperactivity disorder (ADHD), and at present SPD489 is approved for children, adolescents, and adults in the US and Canada, and approved for children in Brazil. In addition to the approved indication of ADHD, other psychiatric disorders such as major depressive disorder may be amenable to amphetamine-based pharmacotherapy. The overall goal of this double-blind study will be to provide placebo-controlled information in establishing the dose response relationship of SPD489 doses (10, 30, 50, and 70mg) using the MADRS. This forced-dose study is expected to provide further support for the SPD489 dose range (20, 30, 50, and 70mg) to be used in Phase 3 trials.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  12/WM/0385

• Date of REC Opinion

  21 Dec 2012

• REC opinion

  Further Information Favourable Opinion