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

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: eszopiclone (Drug); eszopiclone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sepracor, Inc.

Official(s) and/or principal investigator(s):
CNS Medical Director, Study Director, Affiliation: Sepracor, Inc.

Overall contact:
Sepracor Central Contact, Phone: 866-503-7813

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

Official title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.

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

Primary outcome: Change in HAM-A Total Score

Secondary outcome:

Change in HAM-A

Change in individual item scores on HAM-A

Change in CGI-S

CGI-I

HAM-A response, time to onset of response

Remission, time to onset of remission

Change in QLESQ Short Form

Change in ISI total score

Change in SDS

ESS, Change in ESS

Detailed description: This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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 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 of

Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.

- Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any

psychotic, 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 of

SSRI, 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, continued

psychotherapy 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.

Sepracor Central Contact, Phone: 866-503-7813

Birmingham, Alabama 35226, United States; Recruiting

Glendale, California 91206, United States; Recruiting

Burbank, California 91506, United States; Recruiting

Beverly Hill, California 90210, United States; Recruiting

San Diego, California 92123, United States; Recruiting

Paramount, California 90723, United States; Withdrawn

Arcadia, California 91007, United States; Recruiting

Oceanside, California 92056, United States; Recruiting

Newport Beach, California 92660, United States; Recruiting

Pasadena, California, United States; Recruiting

Stanford, California, United States; Recruiting

Glendale, California, United States; Withdrawn

Norwich, Connecticut 06360, United States; Recruiting

Farmington, Connecticut, United States; Recruiting

Bradenton, Florida 34208, United States; Withdrawn

Gainsville, Florida 32607, United States; Recruiting

West Palm Beach, Florida 33407, United States; Recruiting

St. Petersburg, Florida 33702, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Tampa, Florida 33613, United States; Recruiting

Atlanta, Georgia 30328, United States; Not yet recruiting

Smyrna, Georgia 30080, United States; Recruiting

Hoffman Estates, Illinois 60194, United States; Recruiting

Overland Park, Kansas 66212, United States; Recruiting

Prairie Village, Kansas 66206, United States; Recruiting

Baltimore, Maryland 21208, United States; Recruiting

Braintree, Massachusetts 02184, United States; Recruiting

Boston, Massachusetts, United States; Recruiting

Cherry Hill, New Jersey 08002, United States; Recruiting

Clementon, New Jersey, United States; Recruiting

Cedarhurst, New York 11516, United States; Recruiting

New York, New York 10023, United States; Recruiting

New York, New York 10021, United States; Recruiting

Fresh Meadows, New York 11366, United States; Recruiting

Staten Island, New York, United States; Recruiting

Raleigh, North Carolina 27609, United States; Recruiting

Bismarck, North Dakota 58501, United States; Recruiting

Beachwood, Ohio 44122, United States; Recruiting

Dayton, Ohio 45408, United States; Recruiting

Cincinnati, Ohio 45242, United States; Recruiting

Middleburg Heights, Ohio 44130, United States; Recruiting

Oklahoma City, Oklahoma 73103, United States; Recruiting

Eugene, Oregon 97401, United States; Recruiting

Salem, Oregon 97301, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

East Providence, Rhode Island 02915, United States; Recruiting

Memphis, Tennessee 38119, United States; Recruiting

Wichita Falls, Texas 76309, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Austin, Texas 78756, United States; Recruiting

Houston, Texas 77042, United States; Recruiting

Starting date: January 2008
Ending date: March 2009
Last updated: July 30, 2008