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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD7325
AZD7325
AZD7325
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Generalized Anxiety Disorder, GAD, Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A-AZD7325 2mg

B-AZD7325 5mg

C-AZD7325 10mg

D-Placebo

Arm Description

AZD7325 2mg BID

AZD7325 5mg BID

AZD7325 10mg QD

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
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.

Secondary Outcome Measures

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
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.
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
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.
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
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
Change in Sheehan Disability Scale (SDS) Global Total Score
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)

Full Information

First Posted
December 12, 2008
Last Updated
June 15, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00808249
Brief Title
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
Official Title
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Generalized Anxiety Disorder, GAD, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
725 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-AZD7325 2mg
Arm Type
Experimental
Arm Description
AZD7325 2mg BID
Arm Title
B-AZD7325 5mg
Arm Type
Experimental
Arm Description
AZD7325 5mg BID
Arm Title
C-AZD7325 10mg
Arm Type
Experimental
Arm Description
AZD7325 10mg QD
Arm Title
D-Placebo
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD7325
Intervention Description
2 tablets taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
AZD7325
Intervention Description
2 tablets taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
AZD7325
Intervention Description
2 tablets taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 tablets taken twice a day for 28 days
Primary Outcome Measure Information:
Title
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
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.
Time Frame
From randomization (baseline) to week 4
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
Description
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.
Time Frame
From randomization (baseline) to week 4
Title
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
Description
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.
Time Frame
From baseline (randomization) to week 4
Title
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
Description
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
Time Frame
From baseline ( randomization) to week 4
Title
Change in Sheehan Disability Scale (SDS) Global Total Score
Description
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)
Time Frame
From baseline ( randomization) to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Smith, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David V. Sheehan
Organizational Affiliation
University of South Florida College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Arcadia
State/Province
California
Country
United States
Facility Name
Research Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
Chino
State/Province
California
Country
United States
Facility Name
Research Site
City
Encino
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Alamitos
State/Province
California
Country
United States
Facility Name
Research Site
City
Novato
State/Province
California
Country
United States
Facility Name
Research Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Norwich
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Ft Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
St Petersberg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Smyrna
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Libertyville
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Park Ridge
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Cambridge
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Fresh Meadows
State/Province
New York
Country
United States
Facility Name
Research Site
City
Mount Kisco
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
Research Site
City
Beechwood
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Friendswood
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Woodstock
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Herndon
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Middleton
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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

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