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

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ClinicalTrials.gov Identifier: NCT00583193
Recruitment Status : Unknown
Verified December 2007 by New Mexico VA Healthcare System.
Recruitment status was:  Recruiting
First Posted : December 31, 2007
Last Update Posted : December 31, 2007
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
New Mexico VA Healthcare System

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

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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583193


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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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    Key Record Dates
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