CompletedPhase 2

A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD

United Kingdom46 participantsStarted 2024-02-01

Plain-language summary

The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is male or female, of any ethnic origin.
✓. Patient is aged between 18 to 65 years, inclusive.
✓. Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
✓. Patient is ≥50 kg.
✓. Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features based on the Mini-International Neuropsychiatric Interview (MINI) at Screening. Comorbid anxiety disorders (e.g., social anxiety disorder, panic disorder, generalised anxiety disorder, specific phobia, agoraphobia) and cluster C personality disorders (avoidant, dependent and obsessive-compulsive) are allowed, provided that MDD is considered the primary diagnosis.
✓. Current moderate to severe MDD as confirmed with a MADRS-SIGMA total score \>22 and CGI-S score \>3 at Screening and Day -1.
✓. Patient is either not currently taking antidepressants (and hasn't for at least 6 weeks prior to Screening) or is being treated with an SSRI or SNRI antidepressant drug according to national guidelines during the current MDD episode.
✓. Changes in current drug treatment or psychological treatment for depression are not foreseen for the duration of the study.

✕. Current or recent history of clinically significant suicidal ideation or behaviours as defined by:
✕. Suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within 6 months prior to Screening, or
✕. Suicidal behaviours within 1 year prior to Screening, or
✕. Clinical assessment of significant suicidal risk. Patients with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan \>6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the Investigator.
✕. Involuntary psychiatric hospitalisation in the current episode. Previous involuntary psychiatric hospitalisation should be carefully considered and only included at the discretion of the Investigator.
✕. Lifetime diagnosis of any DSM-5 psychotic disorders, bipolar or related disorders, post-traumatic stress disorder (PTSD), complex-PTSD and borderline personality disorder. Other psychiatric disorders besides MDD should not be the primary disorder.
✕. Patient has failed previous treatment with rapidly acting antidepressant drugs, such as NMDA receptor antagonists (e.g., ketamine, esketamine) or 5-HT2A receptor agonists (e.g., psilocybin, DMT, 5-MeO-DMT) or neuromodulating treatments, such as electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation.
✕. Patient is currently or has recently (within 6 weeks prior to Day 1) been treated with antipsychotic medication.

Incidence of Treatment Emergent Adverse Events

Timeframe: Baseline, Day 29

NCT IDNCT06309277

SponsorGilgamesh Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-04

Results submitted2026-04-17

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is male or female, of any ethnic origin.
✓. Patient is aged between 18 to 65 years, inclusive.
✓. Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
✓. Patient is ≥50 kg.
✓. Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features based on the Mini-International Neuropsychiatric Interview (MINI) at Screening. Comorbid anxiety disorders (e.g., social anxiety disorder, panic disorder, generalised anxiety disorder, specific phobia, agoraphobia) and cluster C personality disorders (avoidant, dependent and obsessive-compulsive) are allowed, provided that MDD is considered the primary diagnosis.
✓. Current moderate to severe MDD as confirmed with a MADRS-SIGMA total score \>22 and CGI-S score \>3 at Screening and Day -1.
✓. Patient is either not currently taking antidepressants (and hasn't for at least 6 weeks prior to Screening) or is being treated with an SSRI or SNRI antidepressant drug according to national guidelines during the current MDD episode.
✓. Changes in current drug treatment or psychological treatment for depression are not foreseen for the duration of the study.

✕. Current or recent history of clinically significant suicidal ideation or behaviours as defined by:
✕. Suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within 6 months prior to Screening, or
✕. Suicidal behaviours within 1 year prior to Screening, or
✕. Clinical assessment of significant suicidal risk. Patients with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan \>6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the Investigator.
✕. Involuntary psychiatric hospitalisation in the current episode. Previous involuntary psychiatric hospitalisation should be carefully considered and only included at the discretion of the Investigator.
✕. Lifetime diagnosis of any DSM-5 psychotic disorders, bipolar or related disorders, post-traumatic stress disorder (PTSD), complex-PTSD and borderline personality disorder. Other psychiatric disorders besides MDD should not be the primary disorder.
✕. Patient has failed previous treatment with rapidly acting antidepressant drugs, such as NMDA receptor antagonists (e.g., ketamine, esketamine) or 5-HT2A receptor agonists (e.g., psilocybin, DMT, 5-MeO-DMT) or neuromodulating treatments, such as electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation.
✕. Patient is currently or has recently (within 6 weeks prior to Day 1) been treated with antipsychotic medication.