Clinical trial NCT00097708: Experimental Medication For the Treatment of Generalized Anxiety Disorder
Official title: A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorder
Keywords: Double Blind, Placebo controlled, Safety and Efficacy
Generalized Anxiety Disorder
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-11-30
Enrollment: 511
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 study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HAM-A Total Score
timeFrame: Baseline to week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group, Inc.
state: Alabama
city: Anaheim
country: United States
facility: Crest Clinical Trials, Inc.
state: California
city: Beverly Hills
country: United States
facility: Southwesten Research, Inc.
state: California
city: Burbank
country: United States
facility: Southwestern Research Institute
state: California
city: San Diego
country: United States
facility: University of California - San Diego - Dept of Psychiatry
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: DeLand
country: United States
facility: ACT Clinical Research
state: Florida
city: DeLand
country: United States
facility: University Clinical Research DeLand, Inc.
state: Florida
city: Gainsville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Institute of Research in Psychiatry
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Marietta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Boise
country: United States
facility: Radiant Research
state: Idaho
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Owensboro
country: United States
facility: Peak Medical Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: New Orlean Medical Institute
state: Louisiana
city: Shreveport
country: United States
facility: Brentwood Research Institute
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Pivotal Research Centers - Detroit
state: Michigan
city: St. Louis
country: United States
facility: MedClin Research
state: Missouri
city: Clementon
country: United States
facility: CNS Research Institute (CRI)
state: New Jersey
city: Kenilworth
country: United States
facility: ClinSearch, Inc.
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Neurology and Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Tulsa
country: United States
facility: Laureate Psychiatric Clinic and Hospital
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CNS Research Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Southeast Health Consultants, LLC
state: South Carolina
city: Memphis
country: United States
facility: CNS, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Falls Church
country: United States
facility: Comprehensive Neuroscience of Northern Virginia
state: Virginia
city: Midlothian,
country: United States
facility: Dominion Clinical Research, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: University of California, San Diego
name: Murray Stein, MD
role: STUDY_CHAIR
References: