Safety and PK/PD profile of MSP-1014 in major depressive disorder (MDD) patients

• Research type

  Research Study

• Full title

  An adaptive-design, phase IIa/IIb, open-label, multiple-ascending-dose, dose-finding study to assess the safety, cardiovascular effects, pharmacokinetics and pharmacodynamic profile of 30 mg, 50 mg, and 70 mg of MSP-1014.OX in major depressive disorder (MDD) patients with partial or no response to SSRIs followed by a double-blind, randomised, placebo-controlled, proof-of-concept, efficacy and safety study of the selected dose of MSP-1014.OX in MDD patients with partial or no response to SSRIs.

• IRAS ID

  1006861

• Contact name

  Joseph Araujo

• Contact email

  joseph@mindsetpharma.com

• Sponsor organisation

  Mindset Pharma

• ISRCTN Number

  ISRCTN31103960

• Research summary

  This is an adaptive trial that will be conducted in two parts. In Part 1, 10 participants will receive three single doses of MSP-1014.OX (30mg, 50mg, 70mg) each four weeks apart. The primary objective is to assess the safety, cardiovascular effects, pharmacokinetics, and pharmacodynamic profile of MSP-1014.OX, in patients with major depressive disorder (MDD) who are still experiencing some symptoms despite taking an antidepressant.
  Part 2 is a double-blind randomised trial, comparing the efficacy and safety of the maximum tolerated dose of MSP-1014 identified in Part 1 to placebo. In this part of the trial, approximately 60 patients with MDD who are still experiencing some symptoms despite taking an antidepressant for at least 8 weeks will receive a course of psychotherapy accompanied either MSP-1014.OX or placebo and will be followed up for 8 weeks to assess whether MSP-1014.OX is effective in reducing symptoms of depression.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  23/EE/0032

• Date of REC Opinion

  13 Apr 2023

• REC opinion

  Further Information Favourable Opinion