NCT06236880

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
4mo left

Started Jan 2024

Typical duration for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2024Oct 2026

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

January 23, 2024

Last Update Submit

February 5, 2026

Conditions

Major Depressive Disorder

Keywords

MDDAdjunctiveantidepressant5HT2a agonist

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability (Part A, B, and C)

    The primary objective of this study is to evaluate the safety and tolerability of two doses of GM-2505 administered to MDD patients at a 2-week interval between doses.

    99 Days

  • MADRS Score (Part B and C)

    The estimated difference between Arm 1 and Arm 2 in the changes from baseline in MADRS-SIGMA total score

    29 Days

Secondary Outcomes (4)

  • MADRS-SIGMA total score (Part A)

    Days 14 and 29

  • MADRS-SIGMA total score (Part B and C)

    All additional timepoints

  • MADRS-SIGMA total score (Part B and C)

    Days 14, 29, 43, 71, and 99

  • PK of GM-2505 (Part C)

    Day 16

Study Arms (3)

Low Dose to High Dose of GM-2505

EXPERIMENTAL
Drug: GM-2505

Moderate Dose to High Dose of GM-2505

EXPERIMENTAL
Drug: GM-2505

Experimental very low dose to very low dose of GM-2505

ACTIVE COMPARATOR
Drug: GM-2505

Interventions

GM-2505DRUG

IV

Experimental very low dose to very low dose of GM-2505Low Dose to High Dose of GM-2505Moderate Dose to High Dose of GM-2505

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are male or female, of any ethnic origin.
  • Patients are aged between 18 to 65 years, inclusive.
  • 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.
  • Current moderate to severe MDD diagnosis confirmed with a MADRS-SIGMA
  • Concomitant depression therapy:
  • (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.
  • (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
  • 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.

You may not qualify if:

  • In first degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
  • Current or prior (six weeks before Screening) use of any SSRI/SNRI medication (Part A only).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Gerard Marek, MD

    Gilgamesh Pharmaceuticals

    STUDY CHAIR

Central Study Contacts

Jason Winters

CONTACT

6097385579jason@gilgameshpharmaceutical.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

January 31, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

GB(1)