Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01482221 | A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder | PHASE2 | COMPLETED | 542 | — | — | Dec 16, 2011 | Aug 26, 2013 | Apr 11, 2017 | 44 | United States, Chile +2 |
| NCT00781742 | AZD6765 Severe Major Depressive Disorder (MDD) IV | PHASE2 | COMPLETED | 152 | — | — | Oct 1, 2008 | Mar 1, 2010 | Jul 25, 2012 | 27 | United States |
| NCT01217645 | Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration | PHASE1 | COMPLETED | 6 | — | — | Sep 1, 2010 | Oct 1, 2010 | Oct 13, 2014 | 1 | United Kingdom |
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| 150 mg [14C] AZD6765 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD6765 iv | DRUG | 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion. |
| Placebo | DRUG | 0.9 sodium chloride \[normal saline\] solution for injection by iv infusion |
| AZD6765 | DRUG | IV once per dosing day, multiple times during the treatment period |
| 150 mg [14C] AZD6765 | RADIATION | - |
Inclusion Criteria: * Provision of signed and dated informed consent before initiation of any study-related procedures. * Male or female patients aged 18 to 70 years, inclusive. * The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response ...