Experimental Medication For the Treatment of Generalized Anxiety Disorder

Anxiety Disorder Clinical Trial

Official title:

A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097708
• Other study ID #: JZP 04-001-01
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2004
• Last updated: October 1, 2014
• Start date: November 2004
• Est. completion date: December 2005

Study information

• Verified date: October 2014
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Description:

Protocol 04-001-01

The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).

The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.

Recruiting: Participants are currently being recruited and enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.

Exclusion Criteria:

• No other primary psychiatric diagnosis besides GAD.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• experimental anti-anxiety drug

Locations

Country	Name	City	State
United States	Crest Clinical Trials, Inc.	Anaheim	California
United States	FutureSearch Trials	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	McLean Hospital	Belmont	Massachusetts
United States	Southwesten Research, Inc.	Beverly Hills	California
United States	Birmingham Research Group, Inc.	Birmingham	Alabama
United States	Radiant Research	Boise	Idaho
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Southwestern Research Institute	Burbank	California
United States	Southeast Health Consultants, LLC	Charleston	South Carolina
United States	CNS Research Institute (CRI)	Clementon	New Jersey
United States	Research Across America	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	ACT Clinical Research	DeLand	Florida
United States	University Clinical Research DeLand, Inc.	DeLand	Florida
United States	Oregon Center for Clinical Investigations, Inc.	Eugene	Oregon
United States	Comprehensive Neuroscience of Northern Virginia	Falls Church	Virginia
United States	Sarkis Clinical Trials	Gainsville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	ClinSearch, Inc.	Kenilworth	New Jersey
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Atlanta Institute of Medicine and Research	Marietta	Georgia
United States	Suburban Research Associates	Media	Pennsylvania
United States	CNS, Inc.	Memphis	Tennessee
United States	New Orlean Medical Institute	Metairie	Louisiana
United States	Dominion Clinical Research, Inc.	Midlothian,	Virginia
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	New Britain General Hospital	New Britain	Connecticut
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Peak Medical Research, LLC	Owensboro	Kentucky
United States	CNS Research Institute	Philadelphia	Pennsylvania
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Pivotal Research Centers - Detroit	Royal Oak	Michigan
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	University of California - San Diego - Dept of Psychiatry	San Diego	California
United States	Clinical Innovations	Santa Ana	California
United States	Brentwood Research Institute	Shreveport	Louisiana
United States	MedClin Research	St. Louis	Missouri
United States	Meridien Research	St. Petersburg	Florida
United States	Stanford University Medical Center	Stanford	California
United States	Institute of Research in Psychiatry	Tampa	Florida
United States	Neurology and Neuroscience Center of Ohio	Toledo	Ohio
United States	Laureate Psychiatric Clinic and Hospital	Tulsa	Oklahoma
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HAM-A Total Score	Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.	Baseline to week 8	No