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AZD6765 Severe Major Depressive Disorder (MDD) IV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00781742
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : July 25, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AZD6765 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
100 mg iv once per dosing day
Drug: AZD6765
IV once per dosing day, multiple times during the treatment period

Experimental: 2
150 mg iv once per dosing day
Drug: AZD6765
IV once per dosing day, multiple times during the treatment period

Placebo Comparator: 3 Drug: Placebo
0.9% saline IV once per dosing day multiple times during the treatment period




Primary Outcome Measures :
  1. To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score [ Time Frame: Baseline to week 3 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 weeks ]
  2. 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. [ Time Frame: baseline to Day 1 ]
  3. • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781742


Locations
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United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
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
United States, Connecticut
Research Site
Hartford, Connecticut, United States
Research Site
New Haven, Connecticut, United States
United States, Florida
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
United States, Georgia
Research Site
Atlanta, Georgia, United States
Research Site
Roswell, Georgia, United States
United States, Illinois
Research Site
Hoffman Estates, Illinois, United States
Research Site
Joliet, Illinois, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Louisiana
Research Site
Lake Charles, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
United States, Massachusetts
Research Site
Haverhill, Massachusetts, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New Jersey
Research Site
Willingboro, New Jersey, United States
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States
United States, New York
Research Site
Rochester, New York, United States
United States, Pennsylvania
Research Site
East Stroudsburg, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Michael Castiglione AstraZeneca
Principal Investigator: Gerard Sanacora Yale University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00781742    
Other Study ID Numbers: D6702C00009
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012
Keywords provided by AstraZeneca:
Depression
Depressive Disorder
MDD
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms