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.
The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.
• Patients are male or female, of any ethnic origin.
• Patients are aged between 18 to 65 years, inclusive.
• Patients have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
• Patient is ≥50 kg.
• 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. 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 diagnosis confirmed with a MADRS-SIGMA total score \>22 and total score CGI-S score \> 3 at Screening and Day -1.
• Concomitant depression therapy:
‣ 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.
⁃ 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.