Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2008-10-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
100 mg iv once per dosing day
AZD6765
IV once per dosing day, multiple times during the treatment period
2
150 mg iv once per dosing day
AZD6765
IV once per dosing day, multiple times during the treatment period
3
Placebo
0.9% saline IV once per dosing day multiple times during the treatment period
Interventions
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AZD6765
IV once per dosing day, multiple times during the treatment period
Placebo
0.9% saline IV once per dosing day multiple times during the treatment period
Eligibility Criteria
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Inclusion Criteria
* The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
* Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.
Exclusion Criteria
* Patient has a lifetime history of failure to ECT therapy.
* Patient is pregnant or breast feeding.
* Length of current episode of depression exceeds ≥2 years.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Castiglione
Role: STUDY_DIRECTOR
AstraZeneca
Gerard Sanacora
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
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
Countries
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References
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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.
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.
Other Identifiers
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D6702C00009
Identifier Type: -
Identifier Source: org_study_id