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

Condition(s) targeted: Posttraumatic Stress Disorders

Intervention: Duloxetine hydrochloride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Jose M. Canive, M.D.

Official(s) and/or principal investigator(s):
Jose M Canive, M.D., Principal Investigator, Affiliation: New Mexico VA Health Care System

Overall contact:
Lawrence A Calais, R.N., Phone: 505-265-1711, Ext: 2677, Email: lawrence.calais@va.gov

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

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

Study design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)

Secondary outcome: Visual Analog Scale for Pain (VAS)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients ages 18 or older of any ethnic background meeting DSM-IV

criteria for PTSD

- Score of at least 60 on the CAPS-SX at baseline

- Competent to give informed consent

- If female, patient should be using a medically approved contraceptive, or not

otherwise be of childbearing potential

- Patients who have not taken medications or herbal remedies for a psychiatric

indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an MAOI

- Other medications, if any, must have been kept stable for at least one month prior to

the baseline visit

Exclusion Criteria:

- Known hypersensitivity to duloxetine or any of the inactive ingredients

- Females who are pregnant or breastfeeding

- Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use

during study as specified in Concomitant Medications section) within one week prior to the baseline visit and throughout the study period

- Use of fluoxetine or an MAOI within two weeks

- Concomitant use of narrow therapeutic index medications or medications that are

likely to have a clinically significant drug interaction with duloxetine

- Medical conditions that may prevent safe administration of duloxetine including end

stage renal disease, clinically significant renal impairment (CrCl <30 mL/min), hepatic insufficiency, cardiac disease, or pulmonary disease

- Patients with uncontrolled narrow-angle glaucoma

- Alcohol or drug abuse or dependence within three months of study entry as defined by

DSM-IV criteria

- Alcohol use may not exceed 12 drinks per week or 5 drinks per drinking episode during

the course of the study.

- A current or past history of bipolar disorder, schizophrenia, schizoaffective

disorder or other psychotic disorder

- Suicidal or homicidal ideation or other clinically significant dangerous behavior

- Currently seeking compensation or increase in compensation for the effects of the

trauma

- Initiation or change in psychotherapy within 3 months of study entry

Lawrence A Calais, R.N., Phone: 505-265-1711, Ext: 2677, Email: lawrence.calais@va.gov

New Mexico VA Health Care System, Albuquerque, New Mexico 87108, United States; Recruiting
Jose M Canive, M.D., Principal Investigator

Starting date: December 2005
Ending date: June 2008
Last updated: December 20, 2007