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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders

Intervention: AZD7325 (Drug); AZD7325 (Drug); Lorazepam (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mark A. Smith, MD, PhD, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score

Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Mesa, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, 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, 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, Atlanta, Georgia, United States

Research Site, Hoffman Estates, Illinois, United States

Research Site, Oak Brook, Illinois, United States

Research Site, Schaumburg, Illinois, United States

Research Site, Lafayette, Indiana, United States

Research Site, Terre Haute, Indiana, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Glen Burnie, Maryland, United States

Research Site, Westminster, Maryland, United States

Research Site, Braintree, Massachusetts, United States

Research Site, Piscataway, New Jersey, United States

Research Site, Cedarhurst, New York, United States

Research Site, New York, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Raleigh, North Carolina, United States

Research Site, 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 City, Oklahoma, United States

Research Site, Eugene, Oregon, United States

Research Site, Salem, Oregon, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Charleston, South Carolina, United States

Research Site, Bartlett, Tennessee, United States

Research Site, 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, Richmond, Virginia, United States

Research Site, Seattle, Washington, United States

Additional Information

Starting date: December 2008
Last updated: September 16, 2010

Page last updated: August 23, 2015

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