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Sponsors and Collaborators: |
Jose M. Canive, M.D. Eli Lilly and Company |
Information provided by: | New Mexico VA Healthcare System |
ClinicalTrials.gov Identifier: | NCT00583193 |
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
Condition | Intervention | Phase |
Posttraumatic Stress Disorders |
Drug: Duloxetine hydrochloride |
Phase III |
MedlinePlus related topics: | Post-Traumatic Stress Disorder Stress |
Drug Information available for: | Duloxetine Duloxetine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD. |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
1
Open-label Study
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lawrence A Calais, R.N. | 505-265-1711 ext 2677 | lawrence.calais@va.gov |
Contact: Jose M Canive, M.D. | 505-265-1711 ext 4935 | jose.canive@va.gov |
United States, New Mexico | |||||
New Mexico VA Health Care System | Recruiting | ||||
Albuquerque, New Mexico, United States, 87108 | |||||
Principal Investigator: Jose M Canive, M.D. |
Jose M. Canive, M.D. |
Eli Lilly and Company |
Principal Investigator: | Jose M Canive, M.D. | New Mexico VA Health Care System |
Responsible Party: | New Mexico VA Health Care System ( Jose M. Canive, M.D. ) |
Study ID Numbers: | F1J-US-X024 |
First Received: | December 20, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00583193 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
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