ELICE-BD

• Research type

  Research Study

• Full title

  A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)

• IRAS ID

  232197

• Contact name

  Allan Young

• Sponsor organisation

  University of British Columbia

• Eudract number

  2019-002213-19

• Clinicaltrials.gov Identifier

  NCT02731612

• Clinicaltrials.gov Identifier

  200603 , Latuda FDA (NDA) number; 193350, Health Canada NOL Control Number

• Duration of Study in the UK

  3 years, 5 months, 31 days

• Research summary

  This is a randomised, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of Lurasidone (the study drug) in Bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomised at the baseline visit to receive either Lurasidone or Placebo adjunctive therapy in a 1:1 ratio for 6 weeks.

  Participants will have 4 clinical appointments and 3 telephone assessments during the study. A follow-up telephone interview will be conducted two weeks after the final study visit to assess safety.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0501

• Date of REC Opinion

  19 Sep 2019

• REC opinion

  Further Information Favourable Opinion