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View Clinical Trial (Medical Research Study)
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Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD) - NCT00766064-06516 (Clinical Trial 244708)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy244708.aspx
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| City: |
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West Haven |
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State:
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CT |
| Zip Code: |
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06516 |
| Conditions: |
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Posttraumatic Stress Disorder |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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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| Study is available at: |
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VA Connecticut Healthcare System
West Haven, CT 06516
United States
Primary Contact:
Alexander Neumeister, MD
Email: alexander.neumeister@yale.edu
Phone: 203-932-5711
Secondary Contact:
Sue Kasserman
Email: sue.kasserman@va.gov
Phone: 203-932-5711 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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