Actively Recruiting
A Phase 2a Study to Evaluate the Safety and Tolerability of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients With Major Depressive Disorder
Led by Gilgamesh Pharmaceuticals · Updated on 2026-02-09
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary antidepressant effects of GM-2505 in adults with Major Depressive Disorder (MDD). This Phase 2a study has three parts: Part A focuses on patients not currently using antidepressants, Part B on those partially responding to a single SSRI or SNRI treatment, and Part C aims to replicate Part A findings using a lower dose control group. The study investigates how GM-2505 performs under different patient conditions and doses. The study involves administering GM-2505 through intravenous (IV) doses in three groups: low to high dose, moderate to high dose, and a very low dose as an active comparator. Treatments are given twice at a two-week interval. Each part of the study assesses safety and antidepressant effects over specific periods, with Part B and C measuring depression scores up to 29 days and safety tracked for 99 days. Participants will undergo clinical assessments including depression rating scales such as MADRS-SIGMA at multiple time points, along with safety and tolerability evaluations. Pharmacokinetics of GM-2505 are also studied in Part C. Participants are monitored throughout the treatment and follow-up periods, with a total study duration of up to 99 days. The research team aims to understand GM-2505's effects and safety profile in different MDD patient groups.
CONDITIONS
Brief 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...
- Male or female patients of any ethnic origin
- Age between 18 and 65 years inclusive
- Diagnosis of recurrent Major Depressive Disorder without psychotic features confirmed by MINI at screening
- Moderate to severe Major Depressive Disorder confirmed with MADRS-SIGMA
- For Part A: No SSRI or SNRI treatment for at least 6 weeks before screening and willingness to avoid new pharmacological treatment during the study
- For Part B: Stable SSRI or SNRI treatment for at least 6 weeks before screening and willingness to continue during the trial
- Receiving psychotherapy or counselling at screening and willingness to continue until the end of study assessments
You will not qualify if you...
- Current or past primary diagnosis of psychotic disorders, bipolar or related disorders, PTSD, complex PTSD, or borderline personality disorder
- Primary psychiatric disorder other than Major Depressive Disorder
- First-degree relatives with history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder, or schizoaffective disorder
- Current or prior use of SSRI/SNRI medication within 6 weeks before screening for Part A
- Current or prior use of monoamine oxidase inhibitors or tricyclic antidepressants within 5 weeks before screening
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive two repeated intravenous doses of GM-2505 at a 2-week interval to evaluate safety and tolerability.
2 treatment visits (in-person) spaced 2 weeks apart
Duration - Up to 99 days from first dose
Participants are monitored for safety and symptom changes following treatment.
Multiple follow-up visits for assessments up to Day 99
Trial Site Locations
Total: 1 location
1
MAC Clinical Research
Manchester, United Kingdom
Actively Recruiting
Research Team
J
Jason Winters
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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