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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone

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.