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

Korábbi kezelés

• 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.
• 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.
• Use of psychoactive substances (including ketamine, esketamine or psychedelics, excluding cannabis) during the 6 weeks prior to Screening.

Más betegség

• 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 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.
  • 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.
• Changes in current drug treatment or psychological treatment for depression are not foreseen for the duration of the study.