Cns Drugs
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Randomized Controlled Trial Multicenter Study Comparative Study
Sodium oxybate in the treatment of alcohol withdrawal syndrome: a randomized double-blind comparative study versus oxazepam. The GATE 1 trial.
Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. The aim of this phase IV, multicenter, randomized, double-blind, double-dummy study was to evaluate the efficacy of SMO in comparison with oxazepam in the treatment of uncomplicated AWS. ⋯ SMO is as effective as oxazepam, one of the gold standard BDZs, in the treatment of uncomplicated AWS. Due to its tolerability and absence of significant side effects, SMO may be considered a valid alternative choice in the treatment of AWS.
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Randomized Controlled Trial Multicenter Study
The safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer's disease taking cholinesterase inhibitors.
Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. ⋯ Extended-release memantine was efficacious, safe, and well tolerated in this population.
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Randomized Controlled Trial Multicenter Study
Intranasal oxytocin as an adjunct to risperidone in patients with schizophrenia : an 8-week, randomized, double-blind, placebo-controlled study.
Impairment of oxytocinergic function and/or oxytocin receptor genetic abnormalities has been demonstrated in patients with schizophrenia. Oxytocin reverses emotional recognition deficit and might restore sense of trust in patients with schizophrenia. Some short-term studies have shown efficacy and tolerability of oxytocin in patients with schizophrenia. However, there is a lack of evidence on the efficacy and tolerability of oxytocin in patients with schizophrenia beyond 3 weeks. ⋯ Oxytocin as an adjunct to risperidone tolerably and efficaciously improves positive symptoms of schizophrenia. In addition, effects on negative and total psychopathology scores were statistically significant, but likely to be clinically insignificant. The interesting findings from the present pilot study need further replication in a larger population of patients.
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Randomized Controlled Trial Comparative Study
Spectral frequency index monitoring during propofol-remifentanil and propofol-alfentanil total intravenous anaesthesia.
The aim of this study was to evaluate the usefulness of spectral frequency index (SFx) monitoring to assess the depth of anaesthesia during propofol-opioid total intravenous anaesthesia (TIVA). ⋯ As SFx is linearly related to plasma propofol concentration, this index may be used to measure anaesthetic effect during propofol anaesthesia. The results of this clinical trial are consistent with a previous computer-simulated opioid-propofol model with regard to intraoperative and recovery variables, although the recovery occurred at different propofol concentration and SFx values.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Assessing therapeutic efficacy in a progressive disease: a study of donepezil in Alzheimer's disease.
To determine the value of continued donepezil treatment in patients with Alzheimer's disease for whom clinical benefit was initially judged to be uncertain. ⋯ Most patients showed clear clinical benefit during initial donepezil treatment. Among patients for whom clinical benefit was uncertain, improvement in cognition and behaviour were observed for those who continued donepezil treatment compared with the group switched to placebo. Initial decline or stabilisation does not necessarily indicate a lack of efficacy in Alzheimer's disease, and the decision to discontinue treatment should be based on an evaluation of all domains (cognition, behaviour and ADL) and performed at several timepoints.