Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Completed · Phase 2 · Has a placebo group
Conditions studied: Generalized Anxiety Disorder
In brief
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Key facts
- Study ID
- NCT00616655
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 456
- Starts
- 2008-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2016-04-08
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Study site — Arcadia, California, United States
- Southwestern Research, Inc. — Beverly Hills, California, United States
- Southwestern Research, Inc. — Burbank, California, United States
- California Clinical Trials Medical Group — Glendale, California, United States
- California clinical Trials Medical Group — Glendale, California, United States
- Study site — Newport Beach, California, United States
- Excell Research — Oceanside, California, United States
- California Clinical Trials Medical Group — Paramount, California, United States
- Southwestern Research, Inc. — Pasadena, California, United States
- California clinical Trials Medical Group — San Diego, California, United States
- Stanford Universtiy Medical center — Stanford, California, United States
- University of CT Health Center — Farmington, Connecticut, United States
- Comprehensive Psychiatric Care, PC — Norwich, Connecticut, United States
- Florida Clinical Research Center LLC — Bradenton, Florida, United States
- Sarkis Clinical Trials — Gainsville, Florida, United States
- Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
- Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
- Comprehensive NeuroScience, Inc. — St. Petersburg, Florida, United States
- Stedman Clinical Trials, LLC — Tampa, Florida, United States
- Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
- Comprehensive NeuroScience, Inc. — Atlanta, Georgia, United States
- Carmen Research — Smyrna, Georgia, United States
- Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
- Comprehensive NeuroScience, Inc. — Park Ridge, Illinois, United States
- Birmingham Psychiatry Pharaceutical Studies, Inc. — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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