AZD6765 Severe Major Depressive Disorder (MDD) IV
A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants
1 other identifier
interventional
152
1 country
27
Brief Summary
The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 major-depressive-disorder
Started Oct 2008
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 25, 2012
July 1, 2012
1.4 years
October 27, 2008
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
Baseline to week 3
Secondary Outcomes (3)
To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.
3 weeks
To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.
baseline to Day 1
• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.
8 weeks
Study Arms (3)
1
EXPERIMENTAL100 mg iv once per dosing day
2
EXPERIMENTAL150 mg iv once per dosing day
3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed informed consent before any study-related procedures start.
- The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
- Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.
You may not qualify if:
- Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
- Patient has a lifetime history of failure to ECT therapy.
- Patient is pregnant or breast feeding.
- Length of current episode of depression exceeds ≥2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (27)
Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Ana, California, United States
Research Site
Hartford, Connecticut, United States
Research Site
New Haven, Connecticut, United States
Research Site
Boca Raton, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Roswell, Georgia, United States
Research Site
Hoffman Estates, Illinois, United States
Research Site
Joliet, Illinois, United States
Research Site
Overland Park, Kansas, United States
Research Site
Lake Charles, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Haverhill, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Willingboro, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Rochester, New York, United States
Research Site
East Stroudsburg, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Related Publications (2)
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PMID: 34510411DERIVEDSanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
PMID: 24126931DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Castiglione
AstraZeneca
- PRINCIPAL INVESTIGATOR
Gerard Sanacora
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2008
First Posted
October 29, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 25, 2012
Record last verified: 2012-07