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

This study is currently recruiting participants.
Verified by New Mexico VA Healthcare System, December 2007

Sponsors and Collaborators: Jose M. Canive, M.D.
Eli Lilly and Company
Information provided by: New Mexico VA Healthcare System
ClinicalTrials.gov Identifier: NCT00583193
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorders
Drug: Duloxetine hydrochloride
Phase III

MedlinePlus related topics:   Post-Traumatic Stress Disorder    Stress   

Drug Information available for:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.

Further study details as provided by New Mexico VA Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Scale for Pain (VAS) [ Time Frame: Baseline, weeks 1, 2, 4, 8, & 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   20
Study Start Date:   December 2005
Estimated Study Completion Date:   June 2008

Arms Assigned Interventions
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.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Jose M. Canive, M.D.
Eli Lilly and Company

Investigators
Principal Investigator:     Jose M Canive, M.D.     New Mexico VA Health Care System    
  More Information


Responsible Party:   New Mexico VA Health Care System ( Jose M. Canive, M.D. )
Study ID Numbers:   F1J-US-X024
First Received:   December 20, 2007
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00583193
Health Authority:   United States: Institutional Review Board;   United States: Federal Government

Keywords provided by New Mexico VA Healthcare System:
Post Traumatic Stress Disorder  
Duloxetine  
Antidepressants  

Study placed in the following topic categories:
Dopamine
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Serotonin
Duloxetine
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 31, 2008




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