Clinical trial NCT01482221: A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Inadequate Response to Antidepressant Therapy
Channel blocker of the NMDA class of glutamate receptors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 12
measure: Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)
timeFrame: Week 6 to Week 12
measure: Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
timeFrame: Baseline to Week 6
measure: Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6
timeFrame: Baseline to Week 6
measure: Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to Week 12
measure: Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline to Week 12
measure: Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6
timeFrame: Baseline to Week 6
measure: Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Chino
country: United States
facility: Research Site
state: California
city: Lond Beach
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Stanford
country: United States
facility: Research Site
state: California
city: New Heaven
country: United States
facility: Research Site
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Lake City
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: St Petersburg
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: Mount Kisco
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Antofagasta
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Liptovsky Mikulas
country: Slovakia
facility: Research Site
city: Michalovce Stranany
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Tygervalley
country: South Africa
facility: Research Site
Study officials:
affiliation: 1800 Concord Pike, Wilmington, DE 19850
name: Dhaval A Desai, MD
role: STUDY_DIRECTOR
References: