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

Condition(s) targeted: Anxiety Disorders

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

Phase: Phase 2

Status: Recruiting

Sponsored by: AstraZeneca

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

Overall contact:
Ingalill Reinholdsson, Phone: +46 8 553 26448, Email: ingalill.reinholdsson@astrazeneca.com

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.

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: To give evidence of an effect of AZD7325 versus placebo by change in the HAM-A total score from randomization to day 28.

Secondary outcome:

To evaluate the efficacy of AZD7325 versus placebo by change in the HADS-A, HAM-A psychic cluster and HAM-A somatic cluster score from randomization to each assessment time point.

To assess the safety of the treatment with AZD7325 by incidence of AEs, vital signs, changes in laboratory evaluations etc.

To evaluate the effect of AZD7325 versus placebo and lorazepam versus placebo on the health-related quality of life by assessment of: change in QLES-Q-SF percent maximum total score from baseline to each assessment time point.

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.

Ingalill Reinholdsson, Phone: +46 8 553 26448, Email: ingalill.reinholdsson@astrazeneca.com

Research Site, LITTLE ROCK, Arkansas, United States; Not yet recruiting

Research Site, CARSON, California, United States; Not yet recruiting

Research Site, ESCONDIDO, California, United States; Not yet recruiting

Research Site, IRVINE, California, United States; Not yet recruiting

Research Site, REDLANDS, California, United States; Recruiting

Research Site, SHERMAN OAKS, California, United States; Not yet recruiting

Research Site, FORT LAUDERDALE, Florida, United States; Not yet recruiting

Research Site, GAINSVILLE, Florida, United States; Not yet recruiting

Research Site, JACKSONVILLE, Florida, United States; Not yet recruiting

Research Site, MAITLAND, Florida, United States; Not yet recruiting

Research Site, ORLANDO, Florida, United States; Not yet recruiting

Research Site, TAMPA, Florida, United States; Not yet recruiting

Research Site, WEST PALM BEACH, Florida, United States; Not yet recruiting

Research Site, ATLANTA, Georgia, United States; Not yet recruiting

Research Site, NAPERVILLE, Illinois, United States; Not yet recruiting

Research Site, SCHAUMBURG, Illinois, United States; Not yet recruiting

Research Site, LAFAYETTE, Indiana, United States; Not yet recruiting

Research Site, SHREVEPORT, Louisiana, United States; Not yet recruiting

Research Site, GLEN BURNIE, Maryland, United States; Not yet recruiting

Research Site, WESTMINSTER, Maryland, United States; Recruiting

Research Site, BRAINTREE, Massachusetts, United States; Not yet recruiting

Research Site, PISCATAWAY, New Jersey, United States; Not yet recruiting

Research Site, CEDARHURST, New York, United States; Not yet recruiting

Research Site, NEW YORK, New York, United States; Not yet recruiting

Research Site, STATEN ISLAND, New York, United States; Recruiting

Research Site, CINCINNATI, Ohio, United States; Not yet recruiting

Research Site, DAYTON, Ohio, United States; Not yet recruiting

Research Site, OKLAHOMA CITY, Oklahoma, United States; Not yet recruiting

Research Site, EUGENE, Oregon, United States; Not yet recruiting

Research Site, SALEM, Oregon, United States; Not yet recruiting

Research Site, ALLENTOWN, Pennsylvania, United States; Not yet recruiting

Research Site, PHILADELPHIA, Pennsylvania, United States; Not yet recruiting

Research Site, CHARLESTON, South Carolina, United States; Not yet recruiting

Research Site, AUSTIN, Texas, United States; Not yet recruiting

Research Site, DALLAS, Texas, United States; Not yet recruiting

Research Site, SAN ANTONIO, Texas, United States; Not yet recruiting

Research Site, WICHITA FALLS, Texas, United States; Not yet recruiting

Research Site, RICHMOND, Virginia, United States; Not yet recruiting

Research Site, SEATTLE, Washington, United States; Not yet recruiting

Starting date: December 2008
Ending date: November 2009
Last updated: January 27, 2009