Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)

Early Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: Duloxetine

• Registration Number: NCT00763178
• Lead Sponsor: Yale University

Brief Summary

Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound.

Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD.

Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-25
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-04
• Study Completion: 2009-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTSD	Duloxetine	Duloxetine

Primary Outcome Measures

Name	Time	Method
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD	8 weeks

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States