Duloxetine for the Treatment of Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Psychiatric Diagnosis of generalized anxiety disorder (GAD)

• Outpatients

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD

• Clinical Global Impression (CGI) of Severity Score of at least moderate

• Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

Exclusion Criteria:

• Pregnancy or breast feeding

• Serious medical illness

• Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months

• panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year

• lifetime history of bipolar or psychosis

• Any unstable serious medical condition for which duloxetine would not be allowed

• Any use of medications that are not allowed