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Also known as AZD6765 iv
AZD6765 · 6 trials · 3 indications
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.
Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| AZD6765 (150 mg) / Placebo | EXPERIMENTAL | Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. |
| Placebo / AZD6765 (150 mg) | PLACEBO_COMPARATOR | Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. |
| 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 | Single IV infusion of 150 mg AZD6765. |
| Placebo to AZD6765 | DRUG | Single IV infusion of Placebo to AZD6765 |
| 150 mg [14C] AZD6765 | RADIATION | - |
| Ketamine | DRUG | single infusion |
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 ...
AZD6765 is an investigational small molecule developed by AstraZeneca PLC for the treatment of depression, including major depressive disorder and treatment resistant major depressive disorder. It has been studied in Phase 2 clinical trials and is not approved for commercial use. It was administered intravenously in clinical studies.
AZD6765 was studied as a treatment for major depressive disorder and treatment resistant major depressive disorder. Its clinical program included placebo-controlled trials evaluating antidepressant effects in adults with these conditions. It remains investigational and is not an approved therapy for depression or any other indication.
AZD6765 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trial program for the compound, including Phase 1 and Phase 2 studies conducted in the United States, United Kingdom, Chile, Slovakia, and South Africa.
AZD6765 reached Phase 2 clinical development. Three completed trials are listed, including two Phase 2 studies in major depressive disorder and treatment resistant major depressive disorder, plus Phase 1 studies. No trials are currently active, and the drug is not approved for any indication.
AZD6765 has been evaluated in completed trials including NCT01482221, a Phase 2 study in major depressive disorder with 542 patients, and NCT00986479, a Phase 2 study in treatment resistant major depressive disorder with 22 patients. Phase 1 studies NCT01217645 and NCT01046630 examined metabolism and pharmaco MRI effects.
Yes, AZD6765 iv is another name for AZD6765. The intravenous designation reflects the route of administration used in its clinical trials, including the Phase 1 study NCT01217645 that assessed distribution, metabolism, and excretion after single-dose intravenous administration. Both names refer to the same AstraZeneca compound.