Clinical trial NCT00781742: AZD6765 Severe Major Depressive Disorder (MDD) IV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Depressive Disorder
MDD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
timeFrame: Baseline to week 3
Secondary outcomes:
measure: 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.
timeFrame: 3 weeks
measure: 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.
timeFrame: baseline to Day 1
measure: • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Roswell
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: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Haverhill
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Rochester
country: United States
facility: Research Site
state: New York
city: East Stroudsburg
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca
name: Michael Castiglione
role: STUDY_DIRECTOR
affiliation: Yale University
name: Gerard Sanacora
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sanacora 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.