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

Status unconfirmed · Phase 3

Conditions studied: Posttraumatic Stress Disorders

In brief

The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).

Key facts

Study ID

NCT00583193

Run by

Canive, Jose M., M.D.

People needed

20

Starts

2005-12-01

Expected to finish

2008-06-01

Last updated by the study team

2007-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New Mexico VA Health Care System — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

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