Status:
COMPLETED
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Detailed 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 anxie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00616655
Start Date
January 1 2008
End Date
December 1 2008
Last Update
April 8 2016
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Psychiatry Pharaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
2
Arcadia, California, United States, 91007
3
Southwestern Research, Inc.
Beverly Hills, California, United States, 90210
4
Southwestern Research, Inc.
Burbank, California, United States, 91506