Duloxetine for the Treatment of Generalized Anxiety Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803361

F1J-MC-HMFJ (Other Identifier)

11517

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo