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

Inclusion Criteria

• •1. Patient is male or female, of any ethnic origin.
• •2. Patient is aged between 18 to 65 years, inclusive.
• •3. Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
• •4. Patient is ≥50 kg.
• •5. 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.
• •6. Current moderate to severe MDD as confirmed with a MADRS-SIGMA total score \>22 and CGI-S score \>3 at Screening and Day -1.
• •7. 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.
• •a. If the patient is currently being treated with SSRI or SNRI antidepressants, these have been prescribed at a stable dose and the dose has remained unchanged for at least 6 weeks prior to Screening. However, the following medications are not permitted during the study at any time: NMDA receptor antagonists (including ketamine, esketamine) and 5-HT2A receptor agonists (including psilocybin, DMT, 5-MeO-DMT). No augmentation strategies will be permitted.
• •8. Changes in current drug treatment or psychological treatment for depression are not foreseen for the duration of the study.