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The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | IV placebo |
|
| GLYX-13, 1 mg/kg | Experimental |
| |
| GLYX-13, 5 mg/kg | Experimental |
| |
| GLYX-13, 10 mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYX-13 | Drug | single IV dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression score | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BPRS+ | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M Burch, MD, PhD | Naurex, Inc, an affiliate of Allergan plc | Study Director |
| Vishaal Mehra, MD | Artemis Clinical Research, San Diego CA | Principal Investigator |
| Raymond Manning, MD | CNRI-LA, Pico Rivera CA | Principal Investigator |
| Paul Gross, MD | Lehigh Center for Clinical Research, Allentown PA | Principal Investigator |
| Surinder Randhawa, MD | Lynn Health Sciences Institute, Oklahoma City OK | Principal Investigator |
| David Greuner, MD | CRI-WW, Philadelphia PA | Principal Investigator |
| David Krefetz, DO | CRI-WW Lordes Hospital, Willingboro NJ | Principal Investigator |
| Benji Kurian, MD | U Texas SW Medical Center, Dallas TX | Principal Investigator |
| Michael Lesem, MD | Claghorn-Lesem Research Clinic, Houston TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulitple | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25782764 | Derived | Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2014 | |
| Reset | Oct 11, 2014 | |
| Release | Jul 17, 2015 | |
| Reset | Aug 11, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2014 | Oct 11, 2014 | |||
| Jul 17, 2015 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
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| Matthew Macaluso, MD | Clinical Research Center, Univ Kansas, Wichita KS | Principal Investigator |
| Stephen Murray, MD PhD | Clinilabs, New York, NY | Principal Investigator |
| Aug 11, 2015 |
| D001519 |
| Behavior |