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

NCT ID: NCT01482221

Last Updated: 2017-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-16

Study Completion Date

2013-08-26

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD6765 iv

Intervention Type DRUG

50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.

2

Group Type EXPERIMENTAL

AZD6765 iv

Intervention Type DRUG

100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9 sodium chloride \[normal saline\] solution for injection by iv infusion

Interventions

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AZD6765 iv

50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.

Intervention Type DRUG

AZD6765 iv

100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.

Intervention Type DRUG

Placebo

0.9 sodium chloride \[normal saline\] solution for injection by iv infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dhaval A Desai, MD

Role: STUDY_DIRECTOR

1800 Concord Pike, Wilmington, DE 19850

Locations

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Research Site

Chino, California, United States

Site Status

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Lond Beach, California, United States

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San Diego, California, United States

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Stanford, California, United States

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New Heaven, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Gainsville, Florida, United States

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Lake City, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Skokie, Illinois, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Willingboro, New Jersey, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Bellevue, Washington, United States

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Antofagasta, , Chile

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Santiago, , Chile

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Bratislava, , Slovakia

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Liptovský Mikuláš, , Slovakia

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Michalovce Stranany, , Slovakia

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Rimavská Sobota, , Slovakia

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Svidník, , Slovakia

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Trnava, , Slovakia

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Tygervalley, , South Africa

Site Status

Countries

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United States Chile Slovakia South Africa

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=575&filename=D6702C00031_AZD6765_CSR_Synopsis.pdf

D6702C00031\_Clinical Study Report\_Synopsis

Other Identifiers

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EudraCT number 2011-004690-87

Identifier Type: -

Identifier Source: secondary_id

D6702C00031

Identifier Type: -

Identifier Source: org_study_id

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