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

Posttraumatic Stress Disorders Clinical Trial

Official title:

A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00583193
• Other study ID #: F1J-US-X024
• Status: Recruiting
• Phase: Phase 3
• First received: December 20, 2007
• Last updated: December 20, 2007
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2007
• Source: New Mexico VA Healthcare System
• Contact: Lawrence A Calais, R.N.
• Phone: 505-265-1711
• Email: lawrence.calais[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Canive, Jose M., M.D.	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)		Performed at baseline, weeks 1, 2, 4, 8, & 12	No
Secondary	Visual Analog Scale for Pain (VAS)		Baseline, weeks 1, 2, 4, 8, & 12	Yes