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

September 16, 2010 updated by: AstraZeneca

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With 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)

369

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
    • Arizona
      • Mesa, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Carson, California, United States
        • Research Site
      • Escondido, California, United States
        • Research Site
      • Glendale, California, United States
        • Research Site
      • Irvine, California, United States
        • Research Site
      • Redlands, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Sherman Oaks, California, United States
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Gainsville, Florida, United States
        • Research Site
      • Hallandale Beach, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • St. Petersburg, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Research Site
      • Oak Brook, Illinois, United States
        • Research Site
      • Schaumburg, Illinois, United States
        • Research Site
    • Indiana
      • Lafayette, Indiana, United States
        • Research Site
      • Terre Haute, Indiana, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
      • Westminster, Maryland, United States
        • Research Site
    • Massachusetts
      • Braintree, Massachusetts, United States
        • Research Site
    • New Jersey
      • Piscataway, New Jersey, United States
        • Research Site
    • New York
      • Cedarhurst, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Willoughby, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
      • Salem, Oregon, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Bartlett, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Wichita Falls, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, 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
Placebo Comparator: D
Placebo
Drug: Placebo
4 tablets and 1 capsule taken twice a day for 28 days
Experimental: A
AZD7325 5mg twice daily
Drug: AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
Experimental: B
AZD7325 15mg twice daily
Drug: AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
Active Comparator: C
Lorazepam 2mg twice daily
Drug: Lorazepam
4 tablets and 1 capsule taken twice a day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time Frame: Baseline to week 4
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at 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: Baseline to week 4
HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization
Baseline to week 4
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Time Frame: Baseline to week 4

The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.

Change: score at week 4 minus score at randomization
Baseline to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Time Frame: Baseline to week 4
The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.
Baseline to week 4
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
Time Frame: Baseline to week 4

Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.

Change : percentage at week 4 minus percentage at randomization
Baseline 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

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)

October 8, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1140C00014

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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