Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/13/2015 |
| Start Date: | September 2008 |
| End Date: | October 2009 |
| Contact: | Sue Kasserman |
| Email: | sue.kasserman@va.gov |
| Phone: | 203-932-5711 |
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.
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.
Inclusion Criteria:
- willingness to participate in a naturalistic treatment study using paliperidone and
in two fear conditioning tests, one at baseline and one at the end of the 6 weeks
treatment study.
- We will include PTSD subjects on medications (possible medications include
antidepressants, benzodiazepines) who have no or only partial treatment response.
Paliperidone will be added to the existing treatment regime which will remain
unchanged during the study period. PTSD subjects will have a minimum score of 50 on
the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995).
Exclusion Criteria:
- a comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders,
acute or chronic suicidality, acute or chronic unstable medical conditions (including
severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal
CBC, and liver enzymes more than 50% above the upper normal range, not well
controlled blood pressure)
- current diagnosis of substance abuse or dependence
- unsuccessful treatment history with paliperidone
- known hypersensitivity to paliperidone or any of its inactive ingredients
- administration of any investigational drug up to 90 days before entry into the study
- intake of Class 1A (e.g., quinidine, procainamid) or Class III (e.g., amiodaronme,
sotalol) antiarrhythmic medications, antipsychotics, antibiotics (e.g., gatifloxacin,
moxifloxacin) (up to 90 days before entry into the study or during the study)
- subjects with a positive screen for drugs of abuse
- no startle or skin conductance response, or excessively high startle response to the
startle probe (100 dB acoustic stimuli) during the pretest.
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