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AZD6765 for Treatment Resistant Depression

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00491686
First received: June 25, 2007
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Depression
 Drug: AZD6765
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 34
Study Start Date: July 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD6765
    intravenous infusion
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491686

Locations
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
AstraZeneca
Investigators
Study Director: Mark Smith, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD - Emerging Psychiatry Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00491686     History of Changes
Other Study ID Numbers: D6702C00001
Study First Received: June 25, 2007
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Long-term depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013