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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| University of Oxford | OTHER |
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The purpose of this study is to determine the effect of a single dose infusion of AZD 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI (functional Magnetic Resonance Imaging) in depressed subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single infusion |
|
| 2 | Active Comparator | single infusion |
|
| 3 | Placebo Comparator | single infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | single infusion |
| |
| Ketamine |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of BOLD signal in the brain area BA25 | Day1 (at infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score | once during Day -30 to Day -1, twice Day 1 (pre and 4hrs post infusion) [BDI only pre-infusion], once Day 2 (approx 24hrs post infusion), once Day 9-12 | |
| Responses on a computer based battery of behavioral tasks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bill Deakin, Prof | University of Manchester, Neurosciance and Psychiatry Unit, UK | Principal Investigator |
| Guy Goodwin, Prof | University of Oxford, Departmentof Psychiatry, UK | Principal Investigator |
| Malene Jensen | AstraZeneca R&D, Södertälje, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Manchester | United Kingdom | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27133029 | Derived | Downey D, Dutta A, McKie S, Dawson GR, Dourish CT, Craig K, Smith MA, McCarthy DJ, Harmer CJ, Goodwin GM, Williams S, Deakin JF. Comparing the actions of lanicemine and ketamine in depression: key role of the anterior cingulate. Eur Neuropsychopharmacol. 2016 Jun;26(6):994-1003. doi: 10.1016/j.euroneuro.2016.03.006. Epub 2016 Apr 28. |
| Label | URL |
|---|---|
| D2285C00001 Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
single infusion |
|
| Placebo | Drug | single infusion |
|
| Day2 (approx 24 post infusion) |
| Pharmacokinetics of AZD6765 | Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion) |
| Oxford |
| United Kingdom |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |