Actively Recruiting
A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD
Led by Gilgamesh Pharmaceuticals · Updated on 2026-02-09
124
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are male or female, of any ethnic origin
- Age between 18 to 65 years, inclusive
- Meet DSM-5 criteria for recurrent Major Depressive Disorder without psychotic features
- Current moderate to severe MDD diagnosis confirmed by MADRS-SIGMA
- (Part A) No SSRI or SNRI use for at least 6 weeks prior to screening and willing to avoid new antidepressants during the study
- (Part B) Stable treatment with any SSRI or SNRI for at least 6 weeks prior to screening and willing to continue during the study
- Receiving psychotherapy or counseling at screening and willing to continue until study end
You will not qualify if you...
- Current or past diagnosis of psychotic disorder, MDD with psychotic features, bipolar or related disorders
- Current diagnosis of PTSD, complex PTSD, or borderline personality disorder
- Primary psychiatric disorder other than MDD
- First-degree relatives with history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder, or schizoaffective disorder
- (Part A) Use of any SSRI/SNRI medication within 6 weeks before screening
- Use of any monoamine oxidase inhibitor (MAO-I) or tricyclic antidepressant within 5 weeks before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MAC Clinical Research
Manchester, United Kingdom
Actively Recruiting
Research Team
J
Jason Winters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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