Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder (CSP #504)
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ClinicalTrials.gov Identifier: NCT00099983
Recruitment Status :
First Posted : December 22, 2004
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
US Department of Veterans Affairs
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
Patients were recruited initially from 20 VA Medical Centers over a 2-year period. To address low recruitment rates and other issues, 8 sites were discontinued and 6 sites were added during the course of the study.
an atypical antipsychotic indicated...
Placebo Sugar Pill 1 mg/day HS) for...
an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.
(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
Valid diagnostic baseline data were collected on 267 patients randomized to receive risperidone (n=133) and placebo (n=134). The 29 patients with "missing source documents" as reported in Participant Flow were not included in any analyses.