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Recruiting NCT06236880

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

Phase II Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GM-2505.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Drug GM-2505
    IV

Primary outcome measures

  • Safety and Tolerability (Part A, B, and C) [Time frame: 99 Days]
  • MADRS Score (Part B and C) [Time frame: 29 Days]
Secondary outcome measures (4)
  • MADRS-SIGMA total score (Part A) [Time frame: Days 14 and 29]
  • MADRS-SIGMA total score (Part B and C) [Time frame: All additional timepoints]
  • MADRS-SIGMA total score (Part B and C) [Time frame: Days 14, 29, 43, 71, and 99]
  • PK of GM-2505 (Part C) [Time frame: Day 16]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • MAC Clinical Research — Manchester

Identifiers

NCT: NCT06236880 · GM-2505-201 · 2023-000846-40 · M26-286

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗