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
Recruitment status was Recruiting
Sponsor:
Jose M. Canive, M.D.
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
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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
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:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders 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 February 27, 2015