Elias Aboujaoude, MD, MA
Study of SEP-225441 in Subjects with Generalized Anxiety Disorder
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to see if a new drug called SEP-225441 works to treat Generalized Anxiety Disorder (GAD) and if it is safe. SEP-225441 is a low dose version of the drug eszopiclone (Lunesta?). Eszopiclone has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia, which is the inability to sleep or remain asleep during the night. SEP-225441 may be helpful in the treatment of GAD when taken at different times of the day. Although eszopiclone has been approved by the FDA, SEP-225441 has not.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: SEP-225441 (eszopiclone)
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to 50 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Suffering from GAD
Between 18 and 50 years of age
Body Mass Index between 16 and 32
Key Exclusion Criteria:
Taking medication for GAD
Additional Study Details
Official Title:
A Double Blind, Randomized, Placebo Controlled, Multi-center Study Examining the Efficacy and Safety of SEP-225441 in Subjects with Generalized Anxiety DisorderAnticipated start date:
3/17/2008Lead Sponsor:
Sepracor, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Efficacy of SEP-225441 in subjects with Generalized Anxiety Disorder
Secondary Outcomes:
- Safety and tolerability of SEP-225441 in subjects with GAD
Total Number to be Enrolled:
441Total Number to be Enrolled at Stanford:
12More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/12/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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