D1050302: Efficacy and Safety of Lurasidone in Paediatric Subjects

• Research type

  Research Study

• Full title

  A 104-week, Flexible Dose, Open-label, Multicenter, Extension Study to Evaluate the Long Term Safety and Effectivness of Lurasidone in Pediatric Subjects

• IRAS ID

  168177

• Contact name

  Stephen Lawrie

• Contact email

  s.lawrie@ed.ac.uk

• Sponsor organisation

  Sunovion Pharmaceuticals Europe Ltd.

• Eudract number

  2013-001694-24

• Clinicaltrials.gov Identifier

  NCT01914393

• Duration of Study in the UK

  3 years, 3 months, 26 days

• Research summary

  This is an open-label, 104-week, multicentre, extension study designed to evaluate the long-term safety, tolerability and effectiveness, by use of multiple assessments, of variable doses (flexibly dosing - 20, 40, 60 or 80 mg/day) of a study drug (lurasidone) in adolecent children, diagnosed with schizophrenia or bipolar I depression, and who have completed a 6-week treatment period in the preceding studies, D1050301, D1050326 or D1050325 (not UK).

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  15/SS/0012

• Date of REC Opinion

  17 Feb 2015

• REC opinion

  Further Information Favourable Opinion