AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)

June 15, 2011 updated by: AstraZeneca

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

725

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
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Arcadia, California, United States
        • Research Site
      • Beverly Hills, California, United States
        • Research Site
      • Cerritos, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Encino, California, United States
        • Research Site
      • Los Alamitos, California, United States
        • Research Site
      • Novato, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Connecticut
      • Norwich, Connecticut, United States
        • Research Site
    • Florida
      • Ft Myers, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • St Petersberg, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Smyrna, Georgia, United States
        • Research Site
    • Illinois
      • Libertyville, Illinois, United States
        • Research Site
      • Park Ridge, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Cambridge, Massachusetts, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Clementon, New Jersey, United States
        • Research Site
    • New York
      • Fresh Meadows, New York, United States
        • Research Site
      • Mount Kisco, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
    • Ohio
      • Beechwood, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Middleburg Heights, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • Research Site
      • Norristown, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Friendswood, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Vermont
      • Woodstock, Vermont, United States
        • Research Site
    • Virginia
      • Herndon, Virginia, United States
        • Research Site
    • Washington
      • Spokane, Washington, United States
        • Research Site
    • Wisconsin
      • Middleton, Wisconsin, 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent before any study-related procedures start.
  • The patient is previously diagnosed with Generalized Anxiety Disorder.
  • The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Exclusion Criteria:

  • Patient has a lifetime history of schizophrenia or other psychotic disorders
  • Patient has a history of seizures or seizure disorder.
  • Patient is pregnant or breast feeding.
  • Patient has received electroconvulsive treatment (ECT) in the past.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-AZD7325 2mg
AZD7325 2mg BID
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: B-AZD7325 5mg
AZD7325 5mg BID
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: C-AZD7325 10mg
AZD7325 10mg QD
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: D-Placebo
Placebo
Drug: Placebo
2 tablets taken twice a day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time Frame: From randomization (baseline) to week 4
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
From randomization (baseline) to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
Time Frame: From randomization (baseline) to week 4
The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.
From randomization (baseline) to week 4
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
Time Frame: From baseline (randomization) to week 4
The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.
From baseline (randomization) to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
Time Frame: From baseline ( randomization) to week 4
The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms
From baseline ( randomization) to week 4
Change in Sheehan Disability Scale (SDS) Global Total Score
Time Frame: From baseline ( randomization) to week 4
The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)
From baseline ( randomization) to week 4

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Mark A. Smith, MD, PhD, AstraZeneca
  • Principal Investigator: David V. Sheehan, University of South Florida College of Medicine

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

December 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1140C00006

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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