Not Signed In - Pictures
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sponsor of the Study of Fluoxetine in Autism SOFIA clinical trial received Fast Track designation by the US Food and Drug Administration FDA last week thereby affirming the urgent need for medicines that target autism According to the FDA website www fda gov Fast Track is intended to facilitate development and expedite review of drugs to treat serious and life
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Neuropharm Group plc sponsor of the Study of Fluoxetine in Autism SOFIA clinical trial received Fast Track designation by the US Food and Drug Administration FDA last week thereby
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a larger treatment effect among children than adolescents Single site versus multi site did not impact outcome study by week by treatment group interaction F1 521 =0 01 P = 917 Table 3 shows additional outcomes including baseline and exit scores for the CDRS R total score and CDRS R mean factor scores for both age groups by treatment Change scores are also
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in the children than in the adolescents The effect size for change in CDRS R total score was medium for children effect size 0 71 but small for adolescents effect size 0 39 Examining factor scores children showed greater improvement with fluoxetine than placebo on all factors while adolescents showed greater improvement with fluoxetine than placebo on only
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P = 001 but not adolescents 32 6 vs 21 7 P = 128 Remission rates were relatively low over the 8 week trial for both age groups even within the fluoxetine condition Table 4 To examine changes of suicidality in these age groups we examined CDRS R suicide item 13 Table 5 For purposes of these analyses a score of >3 was identified as presence of suicidal
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also had a extended length of illness 22 6±24 1 weeks vs 17 3±20 3 weeks P = 036 and more severe depression at baseline based on CDRS R 59 5±11 1 vs 53 2±9 2 P < 001 Baseline demographic and clinical characteristics were also similar for both treatment groups within each age group However within the child subgroup those on fluoxetine were more
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fluoxetine 11 5 and placebo 13 2 P = 730 No differences were found between children and adolescents on worsening of suicidality 9 7 children 14 3 adolescents P =0 294
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32 33 Fluoxetine was used as an active comparator to venlafaxine ER during the acute and continuation phases patients on fluoxetine stayed on fluoxetine during both maintenance phases During each of the two maintenance phases patients who were responders to venlafaxine were rerandomized to either venlafaxine or placebo for 12 months The primary objective of each
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2 while those receiving fluoxetine continued on fluoxetine This article describes the rationale and design for the PREVENT study and subsequent reports will provide the study results Why Study Recurrent Depression Recurrences of MDD are common 3 Rates of recurrence have been estimated at 40 within 1 year of the index depressive episode and 85 within 15 years 4
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fluvoxamine indinavir itraconazole ketoconazole nelfinavir nefazodone and ritonavir CYP1A2 by fluvoxamine and omeprazole and CYP2C by fluoxetine fluvoxamine and omeprazole 8 Contrary to popular belief bupropion does inhibit CYP2D6 At 300 mg day it produces almost the same magnitude of effect as paroxetine or fluoxetine which is significant because bupropion
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