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.

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 Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorders
• Intervention / Treatment: Drug: Duloxetine hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Open-label Study	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 Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Visual Analog Scale for Pain (VAS)	Baseline, weeks 1, 2, 4, 8, & 12

Collaborators and Investigators

• Sponsor: Canive, Jose M., M.D.
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Jose M Canive, M.D., New Mexico VA Healthcare System

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion (Anticipated): June 1, 2008

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 31, 2007

Study Record Updates

• Last Update Posted (Estimate): December 31, 2007
• Last Update Submitted That Met QC Criteria: December 20, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Duloxetine; Antidepressants; Post Traumatic Stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: F1J-US-X024