To explore the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database (which is maintained by the Food and Drug Administration and has a mandatory reporting requirement) for systemic analysis of cochlear implant complications and treatments and, in so doing, analyze trends in cochlear implant complications for 2 periods, 2002 and pre-1998. Data Sources: All events from 2002 and from before 1998 were considered. Events and action taken were categorized and tabulated. Data Synthesis: Because there was no null hypothesis, statistical analysis (2) was only used in comparing the 2 time frames. Conclusions: Structural limitations of the database, in addition to disparate reporting quality, made systematic analysis difficult. It was noted that spontaneous device failure accounted for the greatest single number of
Aim
Studies characterizing treatment interventions in a naturalistic setting suggest antidepressant and antipsychotic medications may be equally effective in improving clinical outcome in individuals at high risk for first-episode psychosis. Of interest, both beneficial as well as potentially adverse effects have been observed following fluoxetine treatment in a mouse prenatal immune activation model of relevance to psychosis prevention. We sought to extend those findings by examining the effects of fluoxetine, as well as the antipsychotic medication aripiprazole, in a rat prenatal immune activation model.
Methods
Pregnant Sprague-Dawley rats were injected with poly I:C or saline on gestational day 14. Offspring of poly I:C and saline-treated dams received fluoxetine (10.0 mg/kg/d), aripiprazole (0.66 mg/kg/d), or vehicle from postnatal days 35 to 70. Locomotor responses to novelty, saline injection, and amphetamine (1 and 5 mg/kg) were determined at three months, i.e., 21 days following drug discontinuation.
Results
Both fluoxetine and aripiprazole had beneficial effects on behavioral response to amphetamine (1 mg/kg) at 3 months, ameliorating the impact of prenatal immune activation on offspring of poly I:C-treated dams. Significantly, both drugs also exerted effects in offspring of control (saline-treated) dams on locomotor response to injection.
Conclusions
Fluoxetine and aripiprazole pretreatment of poly I:C offspring from postnatal days 35 to 70 stabilized response to amphetamine exposure persisting through 3 months of age, similar to earlier findings in mice that fluoxetine treatment following prenatal immune activation prevented altered locomotor response to amphetamine. The current data also confirm earlier findings of potential adverse behavioral effects in offspring of control dams following treatment with fluoxetine and antipsychotic medications, highlighting the potential for both therapeutic as well as safety concerns with exposure to preventive pharmacological treatments over the course of adolescent development. Further study is needed to determine clinical and epidemiological consequences of these pre-clinical findings.
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