Clinical TrialTreatment-Resistant Depression (TRD)Recruiting

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.

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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

  • Compound10 mg
    via Intranasal• single dose cohort• 1 doses total

    BPL-003 arm mapping confirmed by reviewer: Arm A is the 10 mg intranasal cohort.

Arm B

experimental

Interventions

  • Compound12 mg
    via Intranasal• single dose cohort• 1 doses total

    BPL-003 arm mapping confirmed by reviewer: Arm B is the 12 mg intranasal cohort.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment64 participants
  • Timeline
    Start: 2023-02-10
    End: 2026-11-01
  • Topic
    Treatment-Resistant Depression (TRD)

Study Team

Sponsors & Collaborators

Locations

United Kingdom

Related Publications

Open AccessindividualPrimary

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

This open-label phase 2a trial (n=12) tested a single intranasal dose of 5-MeO-DMT given alongside stable SSRI treatment in adults with treatment-resistant depression and found it was generally well tolerated, with mostly short-lived nasal and stomach side effects. Depressive symptoms fell quickly and stayed lower over 12 weeks in both dose groups.

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