Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Lorazepam; Pregabalin

Criteria

Inclusion Criteria:

• Diagnosis Generalized Anxiety Disorder

• HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline

• Needs pharmacological treatment

Exclusion Criteria:

• Current or past diagnosis of any other DSM IV Axis I disorders

• A history of failed treatment with a benzodiazepine

• Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder