Comparison of Rapastinel,vortioxetine & placebo for severe depression

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo- and Active- controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder

• IRAS ID

  256415

• Contact name

  Allan Young

• Contact email

  allan.young@kcl.ac.uk

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2018-000063-88

• Clinicaltrials.gov Identifier

  136,870, IND Number

• Duration of Study in the UK

  2 years, 2 months, 0 days

• Research summary

  This is a phase III Randomized, Double-blind, Placebo- and Active controlled,
  Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
  Approximately 690 participants, from ages 18 to 75, are to be enrolled from roughly 56 sites from Europe and Canada.
  There will be a 2 week screening period followed by 6 week double blind treatment period and a further 2 week safety follow up period

• REC name

  HSC REC B

• REC reference

  19/NI/0078

• Date of REC Opinion

  19 Apr 2019

• REC opinion

  Unfavourable Opinion