Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GM-2505 · 1 trial · 1 indication
The primary objective of this study is to evaluate the safety and tolerability of two doses of GM-2505 administered to MDD patients at a 2-week interval between doses.
The estimated difference between Arm 1 and Arm 2 in the changes from baseline in MADRS-SIGMA total score
| Arm | Type | Description |
|---|---|---|
| Low Dose to High Dose of GM-2505 | EXPERIMENTAL | - |
| Moderate Dose to High Dose of GM-2505 | EXPERIMENTAL | - |
| Experimental very low dose to very low dose of GM-2505 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GM-2505 | DRUG | IV |
Key Inclusion Criteria: 1. Patients are male or female, of any ethnic origin. 2. Patients are aged between 18 to 65 years, inclusive. 3. Patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features, a...
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