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

Arm | Intervention/treatment |
---|---|
1
Open-label Study
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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
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- 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 ]
- Visual Analog Scale for Pain (VAS) [ Time Frame: Baseline, weeks 1, 2, 4, 8, & 12 ]

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

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