COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

AZD6765 for Treatment Resistant Depression

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. Identifier: NCT00491686
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : January 21, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Depression Drug: AZD6765 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Intervention Details:
  • Drug: AZD6765
    intravenous infusion

Primary Outcome Measures :
  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. [ Time Frame: Change from Baseline ]

Secondary Outcome Measures :
  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. [ Time Frame: each visit; change from baseline ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Depression
  • Inadequate response to an adequate course of antidepressants

Exclusion Criteria:

  • Psychiatric disorder other than depression
  • Pregnancy or lactation
  • Current diagnosis of cancer

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 identifier (NCT number): NCT00491686

Layout table for location information
United States, California
Research Site
Glendale, California, United States
United States, Connecticut
Research Site
Hartford, Connecticut, United States
Research Site
New Haven, Connecticut, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Maryland
Research Site
Rockville, Maryland, United States
Sponsors and Collaborators
Layout table for investigator information
Study Director: Mark Smith, MD, PhD AstraZeneca
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mark A. Smith, MD - Emerging Psychiatry Medical Science Director, AstraZeneca Identifier: NCT00491686    
Other Study ID Numbers: D6702C00001
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Long-term depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders