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

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.

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