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A Study of Risperidone in Children, Adolescents and Young Adults with Autistic Disorder
This study seeks to reactivate the following protocols under one new RPN during the post-study analyses phase of these studies: 04-06-03, 99-04-06-02, 99-05-14-01, and 01-04-16-04.
Due in part to recent developments regarding the etiology of autism, this study seeks to use archived serum samples (collected as part of RPN # 99-04-06-03) for examination of cytokine profile and copper:zinc ratio of 101 subjects with autism who participated in the U.S. RUPP AUTISM Risperidone trial (n = 23 screened with 15 randomized at K.K.I.).
Since the conclusion of the study, additional reports have been developed from these samples and several more are in preparation. We still have remaining samples that could be used to further examine leads that have emerged since we completed the trial.
We also wish to obtain an Alteration or waiver of informed consent. The consent form for # 99-04-06-03 noted that the purpose of the blood test was to examine the association of specific genes with drug response and for safety purposes (e.g., serum prolactin), but did not specifically list cytokine profile and copper:zinc ratio testing as we are just now realizing may produce significant information.
Please note: Throughout the study, these blood samples were sent to UCLA within 24 hours of their collection. The samples KKI sent to UCLA included the subject number, initials, sample collection date and date of birth only. As part of the original protocol, these samples were sent from UCLA to Yale University for analyses and storage in their freezer.
The stored samples are documented by ID number only. The data set includes the same ID number, subject initials and date of birth (to calculate age) only. No new subjects will be seen as part of this protocol.