NCT00583193

Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder

A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Canive, Jose M., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).

Detailed description

Duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. Chronic PTSD is often treated with antidepressants, in fact there are only two FDA-approved treatments for PTSD. Yet many chronic PTSD patients, especially male combat veterans, have a limited response to antidepressant treatment (Baker et al, 1995; Cañive et al, 1998; Hertzsberg et al 2000) and new pharmacotherapies should be investigated.

Conditions

• Posttraumatic Stress Disorders

Interventions

Type	Name	Description
DRUG	Duloxetine hydrochloride	Start 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg.

Timeline

• Start date: 2005-12-01
• Completion: 2008-06-01
• First posted: 2007-12-31
• Last updated: 2007-12-31

Locations

1 site across 1 country: United States