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

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canive, Jose M., M.D.
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

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