A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.

Key facts

Study ID

NCT01482221

Run by

AstraZeneca

People needed

542

Starts

2011-12-16

Expected to finish

2013-08-26

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 to at least 3 antidepressants.
• Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
• Outpatient status at screening and randomization visits.

You may not qualify if…

• Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
• Patients who have had a suicide attempt within the last 6 months.
• Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
• Patients with any history of seizure disorder (except for febrile seizures in childhood).
• Pregnancy or lactation.

Where it is running

• Research Site — Chino, California, United States
• Research Site — Lond Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — Stanford, California, United States
• Research Site — New Heaven, Connecticut, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Gainsville, Florida, United States
• Research Site — Lake City, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Hoffman Estates, Illinois, United States
• Research Site — Joliet, Illinois, United States
• Research Site — Skokie, Illinois, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Willingboro, New Jersey, United States
• Research Site — Mount Kisco, New York, United States
• Research Site — New York, New York, United States

Full record on ClinicalTrials.gov

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