AZD6765 for Treatment Resistant Depression
A Phase IIa, Multi-Center, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess the Antidepressant Effect and Onset of Effect of AZD6765 in Treatment-Resistant Major Depressive Disorder Patients
1 other identifier
interventional
34
1 country
5
Brief Summary
The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Jul 2007
Shorter than P25 for phase_2 depression
5 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
First Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedJanuary 21, 2011
January 1, 2011
4 months
June 25, 2007
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score.
Change from Baseline
Secondary Outcomes (1)
The secondary objective is to assess the safety and tolerability of AZD6765 as assessed by vital signs, physical examination, clinical laboratory evaluations, ECG's and incidence of adverse events.
each visit; change from baseline
Interventions
intravenous infusion
Eligibility Criteria
You may qualify if:
- Diagnosis of Depression
- Inadequate response to an adequate course of antidepressants
You may not qualify if:
- Psychiatric disorder other than depression
- Pregnancy or lactation
- Current diagnosis of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
Research Site
Glendale, California, United States
Research Site
Hartford, Connecticut, United States
Research Site
New Haven, Connecticut, United States
Research Site
Wichita, Kansas, United States
Research Site
Rockville, Maryland, 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
Mark Smith, MD, PhD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 26, 2007
Study Start
July 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
January 21, 2011
Record last verified: 2011-01