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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: AZD6765 iv

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482221

D6702C00031

EudraCT number 2011-004690-87

Details and patient eligibility

About

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.

Full description

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants

Enrollment: 542 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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542 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD6765 iv

Drug: AZD6765 iv

2

Experimental group

Treatment:

Drug: AZD6765 iv

Drug: AZD6765 iv

3

Placebo Comparator group

Treatment:

Drug: Placebo