Clinical TrialParallelMajor Depressive Disorder (MDD)5-MeO-DMTRecruiting

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD

This Phase II, randomised, quadruple-blind, active-dose-controlled trial (n=124) is evaluating intravenous GM-2505 (bretisilocin) in adults with major depressive disorder. The three-part parallel-group study includes participants receiving GM-2505 as monotherapy and partial responders who continue an adequate SSRI or SNRI, with participants assigned to low-to-high, moderate-to-high or very-low-dose sequences. Participants receive two doses of GM-2505 separated by 2 weeks. The study assesses safety and tolerability through Day 99 and preliminary antidepressant efficacy using change in Montgomery-Åsberg Depression Rating Scale scores, including the comparison between treatment groups at Day 29.

Ask Blossom about this trial
Target Enrollment
124 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Continue exploring

Continue exploring this trial

Move from the registry record to the most relevant public research context.

Compound research: 5-MeO-DMTTopic research: Major Depressive Disorder (MDD)Research in United Kingdom

Detailed Description

This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.

Study Arms & Interventions

GM-2505 low dose to high dose

experimental

Interventions

  • 5-MeO-DMT
    via IV• two doses, 2 weeks apart• 2 doses total

    Bretisilocin (GM-2505); represented under Blossom’s 5-MeO-DMT compound record.

GM-2505 moderate dose to high dose

experimental

Interventions

  • 5-MeO-DMT
    via IV• two doses, 2 weeks apart• 2 doses total

    Bretisilocin (GM-2505); represented under Blossom’s 5-MeO-DMT compound record.

GM-2505 very low dose to very low dose

active comparator

Interventions

  • 5-MeO-DMT
    via IV• two doses, 2 weeks apart• 2 doses total

    Bretisilocin (GM-2505); represented under Blossom’s 5-MeO-DMT compound record.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Key 1. Patients are male or female, of any ethnic origin.
  • 2. Patients are aged between 18 to 65 years, inclusive.
  • 3. Patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features, as assessed with the Mini-International Neuropsychiatric Interview (MINI) at Screening.
  • 4. Current moderate to severe MDD diagnosis confirmed with a MADRS-SIGMA
  • 5. Concomitant depression therapy:
  • 1. (Part A) Patients need to be stable and must not have taken any SSRI or SNRI for at least 6 weeks prior to Screening and must be willing to avoid starting a new pharmacological treatment for MDD until the end of the study procedures and assessments. Discontinuing current treatment is not allowed if done for the purposes of achieving eligibility for this study.
  • 2. (Part B) Patients need to be on stable treatment with any SSRI or SNRI for at least 6 weeks prior to screening and must be willing to remain on the SSRI or SNRI for the duration of the trial
  • 3. Patients receiving any form of psychotherapy or counselling must have been receiving therapy at Screening and must be willing to remain in therapy until the end of the study procedures and assessments.
  • Key

Exclusion Criteria

  • 1. Patient has current or past primary DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar, or related disorders. A current diagnosis of PTSD, complex PTSD and borderline personality disorder are exclusionary. Other psychiatric disorders besides MDD should not be the primary disorder.
  • 2. In first degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
  • 3. Current or prior (six weeks before Screening) use of any SSRI/SNRI medication (Part A only).
  • 4. Current or prior (five weeks before Screening) use of any monoamine oxidase inhibitor (\[MAO-I\]; including phenelzine, tranylcypromine, isocarboxazid, iproniazid, selegiline, rasagiline, the reversible MAO-I moclobemide and the antibiotic linezolid).or any tricyclic antidepressant

Study Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment124 participants
  • Timeline
    Start: 2024-01-31
    End: 2026-10-01
  • Compound
    5-MeO-DMT
  • Topic
    Major Depressive Disorder (MDD)

Study Team

Sponsors & Collaborators

Locations

MAC Clinical Research — Manchester, United Kingdom

Recent activity

  • StartedA Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD (NCT06236880, 5-meo-dmt)

Your Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans