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

• Status: Completed
• Trial end date: 2013-08-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.