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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorders	Drug: Duloxetine hydrochloride	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.
Study Start Date :	December 2005
Estimated Study Completion Date :	June 2008

Arms and Interventions

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Arm	Intervention/treatment
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 Name: Cymbalta

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Visual Analog Scale for Pain (VAS) [ Time Frame: Baseline, weeks 1, 2, 4, 8, & 12 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

Canive, Jose M., M.D.

Eli Lilly and Company

Investigators

Principal Investigator:	Jose M Canive, M.D.	New Mexico VA Healthcare System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jose M. Canive, M.D., New Mexico VA Health Care System
ClinicalTrials.gov Identifier:	NCT00583193 History of Changes
Other Study ID Numbers:	F1J-US-X024
First Posted:	December 31, 2007
Last Update Posted:	December 31, 2007
Last Verified:	December 2007

Keywords provided by New Mexico VA Healthcare System:

Post Traumatic Stress Disorder; Duloxetine; Antidepressants

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Duloxetine Hydrochloride; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs; Dopamine Agents