Evaluating GM-2505 for treating major depressive disorder

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.

This study is testing a new treatment called GM-2505 to see if it can help adults with major depressive disorder feel better while they are also on their usual depression medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Gilgamesh Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Manchester)
• Trial ID: NCT06236880 on ClinicalTrials.gov

What this trial studies

This Phase 2a study aims to assess the safety and tolerability of GM-2505 in patients diagnosed with Major Depressive Disorder (MDD). The study will involve male and female participants aged 18 to 65 who meet specific diagnostic criteria for recurrent MDD without psychotic features. The primary focus is on evaluating the preliminary antidepressant efficacy of GM-2505 while ensuring that participants are stable on any concomitant depression therapy. The study will utilize standardized assessment tools to confirm the severity of depression in participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of recurrent major depressive disorder without psychotic features.

Not a fit: Patients with mild depression or those whose primary diagnosis is not major depressive disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from major depressive disorder.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in assessing new treatments for major depressive disorder.

Eligibility criteria

Key Inclusion Criteria:

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

Where this trial is running

Manchester

• MAC Clinical Research — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Jason Winters

Conditions Major Depressive Disorder; MDD; Adjunctive; antidepressant; 5HT2a agonist