Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD)
Status:
Withdrawn
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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. Antidepressants,
including selective serotonin reuptake inhibitors (SRIs) or norepinephrine-serotonin
re-uptake inhibitors are considered treatment of first choice for these patients, however a
substantial portion of patients do not respond sufficiently (Zhang and Davidson 2007).
Therefore, there is a need to establish novel and effective add-on treatment strategies for
these patients. Recently, atypical neuroleptics have received considerable attention since it
was shown in multiple controlled and naturalistic trials that these medications are an
effective treatment option for patients with PTSD (Davis et al 2006). In chronic PTSD, the
psychophysiological responses at baseline and in response to treatment have yet been
inadequately studied and may provide novel insight into antidepressant and anxiolytic
mechanisms of medications used in the treatment of PTSD. Therefore, in addition to evaluating
the antidepressant and anxiolytic effects of paliperidone, a novel atypical neuroleptic, in
the treatment of PTSD, we also aim to compare neurophysiological responses at baseline with
post-treatment effects in antidepressant-refractory PTSD patients.
Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of paliperidone in patients
with PTSD.
Secondary Aim 2: Evaluate the effects of paliperidone on fear conditioned psychophysiological
responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat
interval) at baseline and after 6 weeks of naturalistic treatment in chronic PTSD patients.