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

Phase 3

• Conditions: Posttraumatic Stress Disorders
• Interventions: Drug: Duloxetine hydrochloride

• Registration Number: NCT00583193
• Lead Sponsor: Canive, Jose M., M.D.

Brief 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.

Study Timeline

• Study Start: 2005-12
• Status Verified: 2007-12
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Last Update Submitted: 2007-12-20
• Study First Posted: 2007-12-31
• Last Update Posted: 2007-12-31
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Duloxetine hydrochloride	Open-label Study

Primary Outcome Measures

Name	Time	Method
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)	Performed at baseline, weeks 1, 2, 4, 8, & 12

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain (VAS)	Baseline, weeks 1, 2, 4, 8, & 12

Trial Locations

Locations (1)

New Mexico VA Health Care System; 🇺🇸 Albuquerque, New Mexico, United States