AZD6765 for Treatment Resistant Depression

January 20, 2011 updated by: AstraZeneca

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

The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States
        • Research Site
      • New Haven, Connecticut, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Maryland
      • Rockville, Maryland, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
each visit; change from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Mark Smith, MD, PhD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6702C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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