Clinical TrialTreatment-Resistant Depression (TRD)5-MeO-DMT5-MeO-DMTRecruiting

An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

This open-label Phase IIa trial (n=64) evaluates the safety and tolerability of up to two doses of 5-MeO-DMT (BPL-003) in patients with treatment-resistant depression (TRD), for which some will receive SSRIs at the same time.

Target Enrollment
64 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, sertraline or fluoxetine).

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

supportive

Study Arms & Interventions

Arm A

experimental

Interventions

  • 5-MeO-DMT

Arm B

experimental

Interventions

  • 5-MeO-DMT

Study Details

Study Team

Sponsors & Collaborators

Locations

United Kingdom

Related Publications

Intranasal 5-MeO-DMT Concomitant with SSRI for Treatment-Resistant Depression: A Proof-of-Concept Trial

Published
Authors
Seynaeve, M., Dunbar, F., Hindocha, C., Ermakova, A. O., Pierce, M., Conley, R. R., Roberts, C.