Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder
Recruitment status was Recruiting
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.|
- PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS) [ Time Frame: Performed at baseline, weeks 1, 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
- Visual Analog Scale for Pain (VAS) [ Time Frame: Baseline, weeks 1, 2, 4, 8, & 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||June 2008|
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.
Other Name: Cymbalta
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.
|Contact: Lawrence A Calais, R.N.||505-265-1711 ext firstname.lastname@example.org|
|Contact: Jose M Canive, M.D.||505-265-1711 ext email@example.com|
|United States, New Mexico|
|New Mexico VA Health Care System||Recruiting|
|Albuquerque, New Mexico, United States, 87108|
|Principal Investigator: Jose M Canive, M.D.|
|Principal Investigator:||Jose M Canive, M.D.||New Mexico VA Health Care System|