Clinical trial NCT00808249: 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
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: 725
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 From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: From randomization (baseline) to week 4
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
timeFrame: From randomization (baseline) to week 4
measure: Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
timeFrame: From baseline (randomization) to week 4
measure: Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
timeFrame: From baseline ( randomization) to week 4
measure: Change in Sheehan Disability Scale (SDS) Global Total Score
timeFrame: From baseline ( randomization) to week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Arcadia
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Chino
country: United States
facility: Research Site
state: California
city: Encino
country: United States
facility: Research Site
state: California
city: Los Alamitos
country: United States
facility: Research Site
state: California
city: Novato
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Norwich
country: United States
facility: Research Site
state: Connecticut
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: St Petersberg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Libertyville
country: United States
facility: Research Site
state: Illinois
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: Fresh Meadows
country: United States
facility: Research Site
state: New York
city: Mount Kisco
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Beechwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
city: Norristown
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Friendswood
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Woodstock
country: United States
facility: Research Site
state: Vermont
city: Herndon
country: United States
facility: Research Site
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Middleton
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Mark A. Smith, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of South Florida College of Medicine
name: David V. Sheehan
role: PRINCIPAL_INVESTIGATOR
References: