Viotra™ in MDD (protocol ETS6103-003)

• Research type

  Research Study

• Full title

  A single centre, double blind, non-inferiority study to evaluate the antidepressant activity of ViotraTM compared with amitriptyline in the treatment of major depressive disorder (MDD) in patients who have an unsatisfactory response/ are resistant to SSRIs.

• IRAS ID

  126537

• Contact name

  GM Crawford

• Sponsor organisation

  E-THERAPEUTICS plc

• Eudract number

  2013-000719-26

• Research summary

  This is a phase II single centre, double blind, parallel study. The plan is to randomise approximately 162 subjects at one centre, who will be referred by local GP practices. After Informed Consent patients will have a screening visit, where demographics, medical, and psychiatric history, and eligibility criteria will be performed. After screening, subjects will start a lead in phase of 6 weeks treatment with citalopram, commencing with 20mg per day for 2 weeks and increasing to 40 mg per day for weeks 3-6. Subjects must have a HAMD-17 score of =18 at the start of the lead in phase. Subjects who have a HAMD-17 score of =12 at the end of the 6 weeks will be randomised to one of three treatment groups (Week 0). Subjects will take 20 mg tramadol or 70 mg tramadol or 75 mg-150mg amitriptyline once daily in the evening over 8 weeks. The subjects will visit the study centre at weeks 1, 2, 4, 6, and 8 for assessment of their mental state and will be followed up by telephone at 28 days after the final visit. On completion of the trial, follow-on treatment will be at the discretion of the GP.

• REC name

  Scotland A REC

• REC reference

  13/SS/0050

• Date of REC Opinion

  26 Mar 2013

• REC opinion

  Favourable Opinion