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

Canive, Jose M., M.D.

Status and phase

Unknown

Phase 3

Conditions

Posttraumatic Stress Disorders

Treatments

Drug: Duloxetine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00583193

F1J-US-X024

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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