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The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 100 mg iv once per dosing day |
|
| 2 | Experimental | 150 mg iv once per dosing day |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | IV once per dosing day, multiple times during the treatment period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score | Baseline to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score. | 3 weeks | |
| To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Castiglione | AstraZeneca | Study Director |
| Gerard Sanacora | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34510411 | Derived | Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3. | |
| 24126931 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 15, 2014 | |
| Reset | Oct 20, 2014 |
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| Placebo |
| Drug |
0.9% saline IV once per dosing day multiple times during the treatment period |
|
| baseline to Day 1 |
| • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs. | 8 weeks |
| Los Angeles |
| California |
| United States |
| Research Site | Orange | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Hartford | Connecticut | United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Gainsville | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Roswell | Georgia | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Haverhill | Massachusetts | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Rochester | New York | United States |
| Research Site | East Stroudsburg | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2014 | Oct 20, 2014 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
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