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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD6765 iv
AZD6765 iv
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, Inadequate Response to Antidepressant Therapy, Channel blocker of the NMDA class of glutamate receptors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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).

Full Information

First Posted
November 28, 2011
Last Updated
April 10, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01482221
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 16, 2011 (Actual)
Primary Completion Date
August 26, 2013 (Actual)
Study Completion Date
August 26, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD, Inadequate Response to Antidepressant Therapy, Channel blocker of the NMDA class of glutamate receptors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
542 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD6765 iv
Intervention Description
50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
Intervention Type
Drug
Intervention Name(s)
AZD6765 iv
Intervention Description
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9 sodium chloride [normal saline] solution for injection by iv infusion
Primary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Baseline to Week 12
Title
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)
Description
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.
Time Frame
Week 6 to Week 12
Title
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
Description
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Time Frame
Baseline to Week 6
Title
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12
Description
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Time Frame
Baseline to Week 12
Title
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6
Description
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Time Frame
Baseline to Week 6
Title
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12
Description
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Description
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).
Time Frame
Baseline to Week 12
Title
Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
Description
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).
Time Frame
Baseline to Week 12
Title
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
Description
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.
Time Frame
Baseline to Week 6
Title
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
Description
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.
Time Frame
Baseline to Week 12
Title
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
Description
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).
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhaval A Desai, MD
Organizational Affiliation
1800 Concord Pike, Wilmington, DE 19850
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chino
State/Province
California
Country
United States
Facility Name
Research Site
City
Lond Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Stanford
State/Province
California
Country
United States
Facility Name
Research Site
City
New Heaven
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Lake City
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
St Petersburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Joliet
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Willingboro
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Mount Kisco
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Antofagasta
Country
Chile
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Michalovce Stranany
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Svidnik
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Tygervalley
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=575&filename=D6702C00031_AZD6765_CSR_Synopsis.pdf
Description
D6702C00031_Clinical Study Report_Synopsis

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

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