Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

Last updated: March 10, 2016
Sponsor: Sunovion
Overall Status: Completed

Phase

2

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00616655
194-027
  • Ages 18-50
  • All Genders

Study Summary

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects must be between 18 and 50 years of age

  • Subjects must have GAD

  • Subjects must be in otherwise good general health

Exclusion

Exclusion Criteria:

  • Subject has a documented history of HIV, hepatitis B or hepatitis C.

  • Subject has a recent history (within 6 months of study entry) or current diagnosis ofMajor Depressive Disorder, panic disorder (or 3 or more panic attacks in the pastmonth). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, orother disorder.

  • Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), anypsychotic, bipolar or schizophrenic disorder.

  • Subject has presence or history of antisocial personality or other severe disorder

  • Subject has refractory GAD (previously unresponsive to 2 or more adequate courses ofSSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).

  • Subject has history of seizures, including febrile seizures.

  • Subject has initiated psychotherapeutic intervention with 30 days; however, continuedpsychotherapy is allowed if stable and not specifically directed at GAD.

  • Subject is undergoing or has undergone electroconvulsive therapy.

  • Subject is a current smoker or has smoked within the last 12 months.

  • Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.

Study Design

Total Participants: 456
Study Start date:
January 01, 2008
Estimated Completion Date:
December 31, 2008

Study Description

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Connect with a study center

  • Birmingham Psychiatry Pharaceutical Studies, Inc.

    Birmingham, Alabama 35226
    United States

    Site Not Available

  • Arcadia, California 91007
    United States

    Site Not Available

  • Southwestern Research, Inc.

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Southwestern Research, Inc.

    Burbank, California 91506
    United States

    Site Not Available

  • California Clinical Trials Medical Group

    Glendale, California 91202
    United States

    Site Not Available

  • California clinical Trials Medical Group

    Glendale, California 91206
    United States

    Site Not Available

  • Newport Beach, California 92660
    United States

    Site Not Available

  • Excell Research

    Oceanside, California 92056
    United States

    Site Not Available

  • California Clinical Trials Medical Group

    Paramount, California 90723
    United States

    Site Not Available

  • Southwestern Research, Inc.

    Pasadena, California 91107
    United States

    Site Not Available

  • California clinical Trials Medical Group

    San Diego, California 92123
    United States

    Site Not Available

  • Stanford Universtiy Medical center

    Stanford, California 94302
    United States

    Site Not Available

  • University of CT Health Center

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • Comprehensive Psychiatric Care, PC

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Florida Clinical Research Center LLC

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Sarkis Clinical Trials

    Gainsville, Florida 32607
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Comprehensive NeuroScience, Inc.

    St. Petersburg, Florida 33702
    United States

    Site Not Available

  • Stedman Clinical Trials, LLC

    Tampa, Florida 33613
    United States

    Site Not Available

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Comprehensive NeuroScience, Inc.

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Carmen Research

    Smyrna, Georgia 30080
    United States

    Site Not Available

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois 60194
    United States

    Site Not Available

  • Comprehensive NeuroScience, Inc.

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Vince and Associats Clinical Research

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Clinical Trials Technology, Inc.

    Prairie Village, Kansas 66206
    United States

    Site Not Available

  • Pedia Research, LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Pharasite Research, Inc.

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Coastal Research Associates, Inc.

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • CRI Worldwide, LLC

    Clementon, New Jersey 08021
    United States

    Site Not Available

  • Social Psychiatry Research Institute

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Comprehensive NeuroScience, Inc.

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Fieve Clinica Services, Inc.

    New York, New York 10021
    United States

    Site Not Available

  • Medical & Behavioral Health Research, P.C.

    New York, New York 10023
    United States

    Site Not Available

  • Medical & Behavioral Health Research, PC

    New York, New York 10021
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Glenwood Psychiatric Associates, P.L.L.C.

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Horizon Medical Services

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • North Coast Clinical Trials

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Patient Priority Clinical Sties, LLC

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Midwest Clinical Research Center

    Dayton, Ohio 45408
    United States

    Site Not Available

  • North Star Mdical Research, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Oregon Center for Clinical Investigations, Inc.

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Oregon Center for Clinical Investigations, Inc.

    Salem, Oregon 97301
    United States

    Site Not Available

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island 02915
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Future Search Trials

    Austin, Texas 78756
    United States

    Site Not Available

  • Carolos Guerra, Jr., M.D.

    Houston, Texas 77042
    United States

    Site Not Available

  • San Antonio Psychiatric Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • University of Virginia, Center for Psychiatric Clinical Research

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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