A dose-finding and proof-of-concept study of the efficacy and safety of MSP-1014.OX in patients with major depressive disorder

This adaptive-design, phase IIa/IIb trial (n=70) aims to assess the safety, cardiovascular effects, pharmacokinetics, and pharmacodynamic profile of MSP-1014.OX (psilocin pro-drug) in patients with major depressive disorder (MDD) who have not responded adequately to SSRIs.

Part 1 of the study involves approximately 10 participants and will be open-label, where three single doses of MSP-1014.OX (30 mg, 50 mg, 70 mg) are administered each 4 weeks apart, to assess safety and tolerability. Part 2 is a double-blind, randomized, placebo-controlled phase involving approximately 60 participants, to compare the efficacy and safety of the maximum tolerated dose of MSP-1014.OX identified in Part 1 to a placebo in reducing symptoms of depression over an 8-week follow-up period.

Participants will receive psychotherapy alongside the medication. This study is funded by Mindset Pharma and is conducted at Clerkenwell Health, UK from January 2023 to October 2024.

Trial Details

This adaptive design clinical trial is to be conducted in two parts: Part 1 is a phase IIa, open-label, multiple-ascending dose, dose-finding study to assess the safety, cardiovascular effects, pharmacokinetics, and pharmacodynamic profile of three oral ascending doses of MSP-1014.OX, namely 30 mg, 50 mg, and 70 mg taken orally, four weeks apart, by MDD patients with partial or no response to SSRIs. Part 1 of the study aims to include 10 evaluable patients with the dose selected for part 2 based on the maximum tolerated dose. Participants will receive 3 sessions of preparatory psychotherapy in the two weeks prior to the first dose of MSP-1014.OX and two sessions of integration therapy following each dose. Participants will be followed up for one week after the final dose. Part 2 of the clinical trial is a phase IIb, double-blind, 1:1 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. Randomisation services will be provided by Sealed Envelope. Part 2 of the study will include approximately 60 patients, although this could increase to a maximum of 82 after interim analysis of the first 40 participants. Half of participants will be allocated to MSP-1014.OX and the other half will be allocated to placebo. All participants will receive 3 sessions of preparatory psychotherapy in the two weeks prior to the dosing session (MSP-1014.OX or placebo) and three sessions of integration therapy in the two weeks following the dosing session. All participants will complete 4-week and 8-week post-baseline follow-up visits. The selected patient population for both parts of the study are patients with a DSM-5 defined MDD diagnosis with moderate to severe symptoms of depression, as defined by a HAM-D score > 17, despite treatment with an adequate dose SSRI for at least 8 weeks.

NCT Number ISRCTN31103960

Data attribution

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