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, a prodrug of psilocin, in patients with major depressive disorder (MDD) who have not adequately responded to selective serotonin reuptake inhibitors (SSRIs).

Conducted in two parts, the study involves a dose-finding phase to evaluate the safety and tolerability of MSP-1014.OX at doses of 30 mg, 50 mg, and 70 mg, followed by a proof-of-concept phase comparing the selected dose to placebo in reducing depression symptoms. Participants aged 18 and above with a DSM-5-defined diagnosis of MDD despite SSRI treatment for at least 8 weeks are eligible to participate.

Part 1 of the trial includes 10 patients who receive three single doses of MSP-1014.OX, while Part 2 comprises approximately 60 participants in a double-blind, randomised, placebo-controlled phase. Participants undergo psychotherapy alongside medication, followed up for 8 weeks to assess the efficacy of MSP-1014.OX in reducing depression symptoms.

The trial is conducted at Clerkenwell Health, UK, from January 2023 to October 2024, funded by Mindset Pharma. Dr. Emilio Arbe and Ms. Clare Knight serve as the main contacts for the study. Study outputs include research summaries provided by the Health Research Authority (HRA).

Topic Depression
Compound Placebo Psilocybin
Country United Kingdom
Visit trial
Status Active, not recruiting
Results Published No
Start date 03 January 2023
End date 30 October 2024
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 70
Sex All
Age 18- 99
Therapy Yes

Trial Details

This trial (n=70) assesses MSP-1014.OX in MDD patients not responding adequately to SSRIs. It includes two phases: dose-finding and proof-of-concept. Participants receive MSP-1014.OX or placebo alongside psychotherapy. Conducted at Clerkenwell Health, UK, from Jan 2023 to Oct 2024, funded by Mindset Pharma.

NCT Number ISRCTN31103960

Sponsors & Collaborators

Clerkenwell Health
Clerkenwell is a clinical research organisation (CRO) in the UK that supports drug developers as they attempt to commercialise psychedelic therapies. Clerkenwell offers support from preclinical studies up to Phase III of the drug development process.

Mindset Pharma
Mindset Pharma is a Toronto-based drug discovery company that aims to develop novel psychedelic drugs.

Data attribution

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