Clinical trial NCT00807937: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder
GAD
Anxiety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
timeFrame: Baseline to week 4
measure: Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
timeFrame: Baseline to week 4
measure: Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
timeFrame: Baseline to week 4
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Carson
country: United States
facility: Research Site
state: California
city: Escondido
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Irvine
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Oak Brook
country: United States
facility: Research Site
state: Illinois
city: Schaumburg
country: United States
facility: Research Site
state: Illinois
city: Lafayette
country: United States
facility: Research Site
state: Indiana
city: Terre Haute
country: United States
facility: Research Site
state: Indiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: Westminster
country: United States
facility: Research Site
state: Maryland
city: Braintree
country: United States
facility: Research Site
state: Massachusetts
city: Piscataway
country: United States
facility: Research Site
state: New Jersey
city: Cedarhurst
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Willoughby
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Mark A. Smith, MD, PhD
role: STUDY_DIRECTOR
References: