Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by New Mexico VA Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00583193
First received: December 20, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.

Resource links provided by NLM:


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.
Other Name: Cymbalta

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: December 20, 2007
Last Updated: December 20, 2007
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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014