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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482221
• Other study ID #: D6702C00031
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2011
• Last updated: April 10, 2017
• Start date: December 16, 2011
• Est. completion date: August 26, 2013

Study information

• Verified date: April 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: August 26, 2013
• Est. primary completion date: August 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• AZD6765 iv
50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
• AZD6765 iv
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
• Placebo
0.9 sodium chloride [normal saline] solution for injection by iv infusion

Locations

Country	Name	City	State
Chile	Research Site	Antofagasta
Chile	Research Site	Santiago
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Liptovsky Mikulas
Slovakia	Research Site	Michalovce Stranany
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Svidnik
Slovakia	Research Site	Trnava
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesburg
South Africa	Research Site	Tygervalley
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Washington
United States	Research Site	Boston	Massachusetts
United States	Research Site	Chino	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Ft. Lauderdale	Florida
United States	Research Site	Gainsville	Florida
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Joliet	Illinois
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Lake City	Florida
United States	Research Site	Lond Beach	California
United States	Research Site	Miami	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mount Kisco	New York
United States	Research Site	New Heaven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Skokie	Illinois
United States	Research Site	St Petersburg	Florida
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stanford	California
United States	Research Site	Willingboro	New Jersey
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Chile,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.	Baseline to Week 6
Secondary	Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.	Baseline to Week 12
Secondary	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)	The percentage of patients with with Sustained Response (defined as =50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.	Week 6 to Week 12
Secondary	Percentage of Patients Who Were Responders (Defined as a =50% Reduction From Baseline in MADRS Total Score) at Week 6	The percentage of patients who were Responders (defined as =50% reduction from baseline in MADRS total score) was calculated.	Baseline to Week 6
Secondary	Percentage of Patients Who Were Responders (Defined as a =50% Reduction From Baseline in MADRS Total Score) at Week 12	The percentage of patients who were Responders (defined as =50% reduction from baseline in MADRS total score) was calculated.	Baseline to Week 12
Secondary	Percentage of Patients Who Were Remitted (Defined as MADRS Total Score =10) at Week 6	The percentage of patients who were Remitted (defined as MADRS total score =10) was calculated.	Baseline to Week 6
Secondary	Percentage of Patients Who Were Remitted (Defined as MADRS Total Score =10) at Week 12	The percentage of patients who were Remitted (defined as MADRS total score =10) was calculated.	Baseline to Week 12
Secondary	Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).	Baseline to Week 12
Secondary	Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score	Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient's illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).	Baseline to Week 12
Secondary	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	A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.	Baseline to Week 6
Secondary	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	A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.	Baseline to Week 12
Secondary	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	A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).	Baseline to Week 12

External Links

•   D6702C00031_Clinical Study Report_Synopsis