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Experimental Medication For the Treatment of Generalized Anxiety Disorder - Article


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Social anxiety disorder (social phobia)


Clinical Trial: Experimental Medication For the Treatment of Generalized Anxiety Disorder

This study is currently recruiting patients.

Sponsored by: Jazz Pharmaceuticals
Information provided by: Jazz Pharmaceuticals

Purpose

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

Condition Treatment or Intervention Phase
Anxiety Disorder
  Drug: experimental anti-anxiety drug
 Phase III

MedlinePlus related topics:  Anxiety

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Measure improvement of anxiety symptoms.
Secondary Outcomes: Remission and response rates of anxiety symptoms.
Expected Total Enrollment:  350

Study start: November 2004;  Expected completion: February 2006
Last follow-up: December 2005;  Data entry closure: January 2006

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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information


California
      Southwesten Research, Inc., Beverly Hills,  California,  90210,  United States; Recruiting
Traci Vilk  310-858-7448 
Darrell Magg  310-858-7448 
John Murphy, MD,  Principal Investigator

      Southwestern Research Institute, Burbank,  California,  91506,  United States; Recruiting
Lauren O'Byrne  818-260-9080 
Dennis Munjack, MD,  Principal Investigator

Colorado
      Alpine Clinical Research Center, Boulder,  Colorado,  80304,  United States; Recruiting
Peg Sharp, RN  303-443-7229 
Alan J. Levine, MD,  Principal Investigator

Florida
      Meridien Research, St. Petersburg,  Florida,  33709,  United States; Recruiting
Annie Sanchez, RN  727-347-8839 
Linda Sirka, RN  727-347-8839 
Mildred Farmer, MD,  Principal Investigator

      Clinical Neuroscience Solutions, Inc., Jacksonville,  Florida,  32216,  United States; Recruiting
Melissa Parsole  904-281-5757 
Mark DeVane  904-281-5757 
George Joseph, MD,  Principal Investigator

      Janus Center for Psychiatric Research, West Palm Beach,  Florida,  33407,  United States; Recruiting
Virginia McClanahan  561-238-3030 
Robert Chaney, BS  561-238-3030 
Janice L. Miller, MD,  Principal Investigator

      Clinical Neuroscience Solutions, Inc., Orlando,  Florida,  32806,  United States; Recruiting
Daphne Tunmore  407-425-5100 
Deborah Renner  407-425-5100 
Richard Saini, MD,  Principal Investigator

Georgia
      Atlanta Institute of Medicine and Research, Marietta,  Georgia,  30060,  United States; Recruiting
Claire Richardson  770-792-9199 
Eric Brubaker  770-792-9199 
Angelo Sambunaris, MD,  Principal Investigator

Kansas
      Vince and Associates Clinical Research, Overland Park,  Kansas,  66211,  United States; Recruiting
Leslie Malone, MS  913-696-1601 
Michelle Neadershiser  913-696-1601 
Bradley D. Vince, DO,  Principal Investigator

Louisiana
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Brian K. Wooten, MA  318-227-4565 
Guy E. Brannon, MD,  Principal Investigator

Maryland
      Pharmasite Research, Inc., Baltimore,  Maryland,  21208,  United States; Recruiting
Toba S. Rudow  410-602-1440 
Christine J. Coogan, MS  410-602-1440 
Robert Lehman, MD,  Principal Investigator

New Jersey
      CNS Research Institute (CRI), Clementon,  New Jersey,  08021,  United States; Recruiting
Maria Pinho, RN  856-566-9000  Ext. 230 
Steven Glass, MD,  Principal Investigator

      ClinSearch, Inc., Kenilworth,  New Jersey,  07033,  United States; Recruiting
Ina Marritt, BS  908-241-1022 
Amanda Wolf, BA  908-241-1022 
Robert Moreines, MD,  Principal Investigator

New York
      Social Psychiatry Research Institute, Brooklyn,  New York,  11235,  United States; Recruiting
Debbi Portnoy  212-249-6829 
Nick G. Vatakis, MD,  Principal Investigator

      Social Psychiatry Research Institute, Brooklyn,  New York,  11235,  United States; Recruiting
Julia Gutkin  718-616-2400 
Inna Yuryev-Golger, MD,  Principal Investigator

Ohio
      Neurology and Neuroscience Center of Ohio, Toledo,  Ohio,  43623,  United States; Recruiting
Pauline Gerard, PhD.  419-841-7369 
Gary Gerard, MD,  Principal Investigator

      Midwest Clinical Research Center, Dayton,  Ohio,  45408,  United States; Recruiting
Cynthia Thompson  937-424-1050 
Bernadette D'Souza, MD,  Principal Investigator

Oklahoma
      IPS Research Company, Oklahoma City,  Oklahoma,  73103,  United States; Recruiting
Aaron Harned  405-235-8188 
Linda Watson  405-235-8188 
Louise M. Beckett, MD,  Principal Investigator

Oregon
      Oregon Center for Clinical Investigations, Inc., Eugene,  Oregon,  97401,  United States; Recruiting
Ruthie E. Knowles  541-341-6565 
Erin J. Tiel  541-341-6565 
James T. Grimm, MD,  Principal Investigator

Pennsylvania
      CNS Research Institute, Philadelphia,  Pennsylvania,  19149,  United States; Recruiting
Margot Oakley  215-624-1300 
Roberta Ball, DO,  Principal Investigator

      Suburban Research Associates, Media,  Pennsylvania,  19063,  United States; Recruiting
Anita Perretta  610-891-9024  Ext. 104 
Shivkumar Hatti, MD,  Principal Investigator

South Carolina
      Southeast Health Consultants, LLC, Charleston,  South Carolina,  29407,  United States; Recruiting
Kaye Roberts  843-763-1914 
Karen Bostick  843-763-1914 
Robert B. Lydiard, MD, PhD,  Principal Investigator

Tennessee
      CNS, Inc., Memphis,  Tennessee,  38119,  United States; Recruiting
Cathy Houpt, LCSW  901-843-1045 
Shannon Smith  901-843-1045 
Valerie Arnold, MD,  Principal Investigator

Texas
      FutureSearch Trials, Austin,  Texas,  78756,  United States; Recruiting
Carolyn Yee  512-380-9925 
Bobbie Theodore  512-380-9925 
Beal G. Essink, MD,  Principal Investigator

Utah
      Lifetree Clinical Research, Salt Lake City,  Utah,  84106,  United States; Recruiting
Alice Jackson, RN  801-269-8200 
Thomas K. Trauba, MD,  Principal Investigator

Virginia
      Dominion Clinical Research, Inc., Midlothian,  Virginia,  23112,  United States; Recruiting
Laurie Burke, MS, CCRC, RN  804-744-6714 
Anne Fedyszen, MD,  Principal Investigator

      Comprehensive Neuroscience of Northern Virginia, Falls Church,  Virginia,  22041,  United States; Recruiting
Anne M. Knapik  703-998-5850 
Monica Grover  703-998-5850 
Ramanath Gopalan, MD,  Principal Investigator

Washington
      Northwest Clinical Research Center, Bellevue,  Washington,  98004,  United States; Recruiting
Christine F. Khan, PhD  425-453-0404 
Arifulla Khan, MD,  Principal Investigator

Study chairs or principal investigators

Murray Stein, MD,  Study Chair,  University of California, San Diego   

More Information

Study ID Numbers:  JZP 04-001-01
Record last reviewed:  January 2005
Last Updated:  January 26, 2005
Record first received:  November 29, 2004
ClinicalTrials.gov Identifier:  NCT00097708
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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November 18, 2008


Page Updated: June 12, 2007
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