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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01482221
First received: November 28, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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 NMDA class of glutamate receptors.


Condition Intervention Phase
Major Depressive Disorder
Drug: AZD6765 iv
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5 and 6. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10 and 12. ] [ Designated as safety issue: No ]
  • Percentage of patients with sustained response, defined as ≥50% reduction from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6 and which is maintained through Week 12 [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10 and 12. ] [ Designated as safety issue: No ]
  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at each scheduled assessment. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ] [ Designated as safety issue: No ]
  • Percentage of responders at each scheduled assessment where responders are defined as patients with a ≥50% reduction from baseline in Montgomery-Asberg Rating Scale (MADRS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ] [ Designated as safety issue: No ]
  • Percentage of patients who are remitted at each scheduled assessment where remission is defined as Montgomery-Asberg Rating Scale (MADRS) total score ≤8. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20. ] [ Designated as safety issue: No ]
  • Change from baseline in functional impairment at each scheduled assessment, as measured by the change from baseline in the Sheehan Disability Scale (SDS) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 6, 12 and 20. ] [ Designated as safety issue: No ]
  • Change in severity of depressive symptoms at each scheduled assessment as measured by change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score. [ Time Frame: Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20. ] [ Designated as safety issue: No ]
  • Change in severity of depressive symptoms at each scheduled assessment as measured by the Clinical Global Impression-Improvement (CGI-I) response. Response in CGI-I is based on whether or not the CGI-I score is ≤2 (very much improved or much improved). [ Time Frame: Will be scored at Weeks 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20. ] [ Designated as safety issue: No ]
  • Change from baseline in self-rated severity of depressive symptoms at each scheduled assessment as measured by Quick Inventory of Depressive Symptomatology Self-Report 16-item scale (QIDS-SR-16) total score. [ Time Frame: Will be scored at Weeks 1 (baseline), 3, 6, 12, 16 and 20. ] [ Designated as safety issue: No ]
  • Adverse events (AEs)/serious adverse events (SAEs), including their severity. [ Time Frame: Will be collected throughout the study period, Weeks 1 through 20. ] [ Designated as safety issue: Yes ]

Enrollment: 302
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD6765 iv
50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
Experimental: 2 Drug: AZD6765 iv
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
Placebo Comparator: 3 Drug: Placebo
0.9 sodium chloride [normal saline] solution for injection by iv infusion

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482221

  Hide Study Locations
Locations
United States, California
Research Site
Chino, California, United States
Research Site
Lond Beach, California, United States
Research Site
San Diego, California, United States
United States, Connecticut
Research Site
New Heaven, Connecticut, United States
United States, Florida
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Ft. Lauderdale, Florida, United States
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Gainsville, Florida, United States
Research Site
Lake City, Florida, United States
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Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
St Petersburg, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
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Decatur, Georgia, United States
United States, Illinois
Research Site
Hoffman Estates, Illinois, United States
Research Site
Joliet, Illinois, United States
Research Site
Skokie, Illinois, United States
United States, Louisiana
Research Site
Lake Charles, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New Jersey
Research Site
Parsippany, New Jersey, United States
Research Site
Willingboro, New Jersey, United States
United States, New York
Research Site
Mount Kisco, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
United States, North Carolina
Research Site
Winston-salem, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
United States, Washington
Research Site
Bellevue, Washington, United States
Chile
Research Site
Antofagasta, Chile
Research Site
Coquimbo, Chile
Research Site
Santiago, Chile
Slovakia
Research Site
Bojnice, 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, Slovakia
South Africa
Research Site
Centurion, Gauteng, South Africa
Research Site
Cape Town, Western Cape, South Africa
Research Site
Tygervalley, Western Cape, South Africa
Research Site
Johannesburg, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dhaval A Desai, MD 1800 Concord Pike, Wilmington, DE 19850
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01482221     History of Changes
Other Study ID Numbers: D6702C00031, EudraCT number 2011-004690-87
Study First Received: November 28, 2011
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Chile: Instituto de Salud Pública de Chile

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD
Inadequate Response to Antidepressant Therapy
Channel blocker of the NMDA class of glutamate receptors

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014