Posttraumatic Stress Disorder Clinical Trial
Official title:
Effects of Duloxetine on Fear Conditioning in PTSD
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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