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

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Generalized Anxiety Disorder

Treatments: Drug: eszopiclone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616655

194-027

Details and patient eligibility

About

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

Full 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 anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Enrollment: 456 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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456 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

SEP-225441 (eszopiclone) total daily dose of 1.5 mg

Treatment:

Drug: eszopiclone

Drug: eszopiclone

2

Active Comparator group

Description:

SEP-225441 (eszopiclone) total daily dose of 0.9 mg

Treatment:

Drug: eszopiclone

Drug: eszopiclone

3

Placebo Comparator group

Description:

Placebo total daily dose 0.9 mg

Treatment:

Drug: Placebo