Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.
1 other identifier
interventional
456
1 country
57
Brief Summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
Shorter than P25 for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
August 21, 2015
CompletedApril 8, 2016
March 1, 2016
11 months
February 4, 2008
June 2, 2015
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
Baseline to Week 8
Secondary Outcomes (10)
Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)
Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)
Change in Individual Item Scores on HAM-A
Baseline, Weeks 2, 4, 6, 8
Change From Baseline in Clinician Global Impression of Severity (CGI-S)
Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
Clinical Global Impression- Improvement (CGI-I)
Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)
Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response
Week 2, 4, 6, 8
- +5 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORSEP-225441 (eszopiclone) total daily dose of 1.5 mg
2
ACTIVE COMPARATORSEP-225441 (eszopiclone) total daily dose of 0.9 mg
3
PLACEBO COMPARATORPlacebo total daily dose 0.9 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Birmingham Psychiatry Pharaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
Unknown Facility
Arcadia, California, 91007, United States
Southwestern Research, Inc.
Beverly Hills, California, 90210, United States
Southwestern Research, Inc.
Burbank, California, 91506, United States
California Clinical Trials Medical Group
Glendale, California, 91202, United States
California clinical Trials Medical Group
Glendale, California, 91206, United States
Unknown Facility
Newport Beach, California, 92660, United States
Excell Research
Oceanside, California, 92056, United States
California Clinical Trials Medical Group
Paramount, California, 90723, United States
Southwestern Research, Inc.
Pasadena, California, 91107, United States
California clinical Trials Medical Group
San Diego, California, 92123, United States
Stanford Universtiy Medical center
Stanford, California, 94302, United States
University of CT Health Center
Farmington, Connecticut, 06032, United States
Comprehensive Psychiatric Care, PC
Norwich, Connecticut, 06360, United States
Florida Clinical Research Center LLC
Bradenton, Florida, 34208, United States
Sarkis Clinical Trials
Gainsville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33702, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, 30328, United States
Carmen Research
Smyrna, Georgia, 30080, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60194, United States
Comprehensive NeuroScience, Inc.
Park Ridge, Illinois, 60068, United States
Vince and Associats Clinical Research
Overland Park, Kansas, 66212, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Pharasite Research, Inc.
Baltimore, Maryland, 21208, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Coastal Research Associates, Inc.
Braintree, Massachusetts, 02184, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
CRI Worldwide, LLC
Clementon, New Jersey, 08021, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Comprehensive NeuroScience, Inc.
Fresh Meadows, New York, 11366, United States
Fieve Clinica Services, Inc.
New York, New York, 10021, United States
Medical & Behavioral Health Research, PC
New York, New York, 10021, United States
Medical & Behavioral Health Research, P.C.
New York, New York, 10023, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Glenwood Psychiatric Associates, P.L.L.C.
Raleigh, North Carolina, 27609, United States
Horizon Medical Services
Bismarck, North Dakota, 58501, United States
North Coast Clinical Trials
Beachwood, Ohio, 44122, United States
Patient Priority Clinical Sties, LLC
Cincinnati, Ohio, 45242, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
North Star Mdical Research, LLC
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02915, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Future Search Trials
Austin, Texas, 78756, United States
Carolos Guerra, Jr., M.D.
Houston, Texas, 77042, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
University of Virginia, Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Williams JB, Kobak KA, Giller E, Reasner DS, Curry L, Detke MJ. Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):654-60. doi: 10.1097/JCP.0000000000000422.
PMID: 26488677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eszopiclone Medical Director
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
CNS Medical Director
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 8, 2016
Results First Posted
August 21, 2015
Record last verified: 2016-03