Status:
WITHDRAWN
Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD)
Lead Sponsor:
Yale University
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 associa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00766064
Start Date
September 1 2008
End Date
November 1 2009
Last Update
August 23 2016
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516