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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD7325
AZD7325
Lorazepam
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

Active Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

AZD7325 5mg twice daily

AZD7325 15mg twice daily

Lorazepam 2mg twice daily

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
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
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
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
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
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.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
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

Full Information

First Posted
December 12, 2008
Last Updated
September 16, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00807937
Brief Title
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
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
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
AZD7325 5mg twice daily
Arm Title
B
Arm Type
Experimental
Arm Description
AZD7325 15mg twice daily
Arm Title
C
Arm Type
Active Comparator
Arm Description
Lorazepam 2mg twice daily
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD7325
Intervention Description
4 tablets and 1 capsule taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
AZD7325
Intervention Description
4 tablets and 1 capsule taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
4 tablets and 1 capsule taken twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 tablets and 1 capsule taken twice a day for 28 days
Primary Outcome Measure Information:
Title
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
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
Time Frame
Baseline to week 4
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
Description
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
Time Frame
Baseline to week 4
Title
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Description
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
Time Frame
Baseline to week 4
Title
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Description
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.
Time Frame
Baseline to week 4
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
Description
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
Time Frame
Baseline 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
Facility Information:
Facility Name
Research Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Carson
State/Province
California
Country
United States
Facility Name
Research Site
City
Escondido
State/Province
California
Country
United States
Facility Name
Research Site
City
Glendale
State/Province
California
Country
United States
Facility Name
Research Site
City
Irvine
State/Province
California
Country
United States
Facility Name
Research Site
City
Redlands
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
Sherman Oaks
State/Province
California
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Schaumburg
State/Province
Illinois
Country
United States
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Research Site
City
Lafayette
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Terre Haute
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Westminster
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Braintree
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Piscataway
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Cedarhurst
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
Staten Island
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
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Willoughby
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Salem
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Bartlett
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
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City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Wichita Falls
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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

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