The present study aimed to: (i) provide preliminary data on the effectiveness and tolerability of atypical antipsychotics, amisulpride (AMSP) and quetiapine (QTP) for patients with delirium and (ii) investigate whether the two drugs affect sleep differently and further relation with the recovery time of delirium. Forty patients with delirium were randomly assigned to either AMSP or QTP groups, with a flexible dosing schedule. The Delirium Rating Scale-revised-98 (DRS-R-98) and clinical global impression-severity (CGI-S), total sleep time and quality of sleep were assessed daily. Sixteen subjects in the AMSP group and 15 subjects in the QTP group completed the study. The mean daily dose was 156.4 mg/day and 113 mg/day in the AMSP and QTP groups, respectively. There was no significant difference in the baseline DRS-R-98 and CGI scores. After treatment, DRS-R-98 scores were significantly decreased from the baseline in both treatment groups (P<0.001) without group difference. The mean duration of stabilization were 6.3+/-4.4 days for the AMSP group and 7.4+/-4.1 days for the QTP group without group differences. There was no group difference in the mean quality of sleep score and the mean total sleep time. The duration of stabilization was inversely correlated with the mean sleep quality score and the mean total sleep time (P<0.001). Both atypical antipsychotics were generally well tolerated. The present study shows that both amisulpride and quetiapine may be useful drugs for the treatment of delirium on the basis of effectiveness and relative lack of adverse events. Further systematic controlled studies are required.
"Seven studies did not describe the randomization process clearly        , and one study was a controlled clinical trial  that had a high risk of allocation concealment and random sequence generation bias. Three studies were open-label studies   , four studies had a single-blind design in which only the outcome assessor was blinded     and three studies    were not blinded. In these cases, there was a high risk of bias in the blinding of the participants and personnel and outcome assessment. "
[Show abstract][Hide abstract] ABSTRACT: Representation of hospitalized patients with pre-existing cognitive impairment in pharmaceutical delirium trials is important because these patients are at high risk for developing delirium. The aim of this systematic review is to investigate whether patients with cognitive impairment were included in studies on pharmacological prophylaxis or treatment of delirium and to explore the motivations for their exclusion (if they were excluded).
This study was a systematic review. A MEDLINE search was performed for publications dated from 1 January 1985 to 15 November 2012. Randomized and non-randomized controlled trials that investigated medication to prevent or treat delirium were included. The number of patients with cognitive impairment was counted, and if they were excluded, motivations were noted.
The search yielded 4293 hits, ultimately resulting in 31 studies that met the inclusion criteria. Of these, five studies explicitly mentioned the percentage of patients with cognitive impairment that were included. These patients comprised a total of 8% (n=279 patients) of the 3476 patients included in all 31 studies. Ten studies might have included cognitively impaired patients but did not mention the exact percentage, and sixteen studies excluded all patients with cognitive impairment. The motivations for exclusion varied, but most were related to the influence of dementia on delirium.
The exclusion of patients with pre-existing cognitive impairment hampers the generalizability of the results of these trials and leaves clinicians with limited evidence about the pharmacological treatment of this group of vulnerable patients who have an increased risk of side effects.
Journal of psychosomatic research 03/2014; 76(3):193-199. DOI:10.1016/j.jpsychores.2013.12.007 · 2.74 Impact Factor
"Some randomized comparative trials assessing the efficacy of various antipsychotics in the treatment of delirium have been conducted in critical care units or consultation-liaison psychiatric services [26,28,32,35-39]. Five trials compared the efficacy between one atypical antipsychotic agent and haloperidol [28,35,36,38,39] and two trials compared the effectiveness of two different atypical antipsychotics [26,37]. One trial assessed the comparative efficacy among two atypical antipsychotics and haloperidol . "
[Show abstract][Hide abstract] ABSTRACT: Most previous studies on the efficacy of antipsychotic medication for the treatment of delirium have reported that there is no significant difference between typical and atypical antipsychotic medications. It is known, however, that older age might be a predictor of poor response to antipsychotics in the treatment of delirium. The objective of this study was to compare the efficacy and safety of haloperidol versus three atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) for the treatment of delirium with consideration of patient age.
This study was a 6-day, prospective, comparative clinical observational study of haloperidol versus atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in patients with delirium at a tertiary level hospital. The subjects were referred to the consultation-liaison psychiatric service for management of delirium and were screened before enrollment in this study. A total of 80 subjects were assigned to receive either haloperidol (N = 23), risperidone (N = 21), olanzapine (N = 18), or quetiapine (N = 18). The efficacy was evaluated using the Korean version of the Delirium Rating Scale-Revised-98 (DRS-K) and the Korean version of the Mini Mental Status Examination (K-MMSE). The safety was evaluated by the Udvalg Kliniske Undersogelser side effect rating scale.
There were no significant differences in mean DRS-K severity or K-MMSE scores among the four groups at baseline. In all groups, the DRS-K severity score decreased and the K-MMSE score increased significantly over the study period. However, there were no significant differences in the improvement of DRS-K or K-MMSE scores among the four groups. Similarly, cognitive and non-cognitive subscale DRS-K scores decreased regardless of the treatment group. The treatment response rate was lower in patients over 75 years old than in patients under 75 years old. Particularly, the response rate to olanzapine was poorer in the older age group. Fifteen subjects experienced a few adverse events, but there were no significant differences in adverse event profiles among the four groups.
Haloperidol, risperidone, olanzapine, and quetiapine were equally efficacious and safe in the treatment of delirium. However, age is a factor that needs to be considered when making a choice of antipsychotic medication for the treatment of delirium.Trial registration: Clinical Research Information Service, Republic of Korea, (http://cris.nih.go.kr, Registered Trial No. KCT0000632).
[Show abstract][Hide abstract] ABSTRACT: The analysis of clinical trials in delirium is typically complicated by treatment dropouts and by the fact that even untreated individuals may have a good prognosis. These features of delirium trials warrant special statistical attention; implications for each stage of a trial planning process are described.
Choice of outcome, patient sample, and data collection in delirium trials are discussed. Descriptions are given, together with examples, of time-to-event, imputation-based, linear and nonlinear models for the analysis of randomised controlled trials for delirium.
Imputation allows evaluation of the plausibility of individual recovery trajectories, but some simple imputations are found to be unsuitable for delirium research. Time-to-event and nonlinear models encourage a global perspective on analysis, which is often preferable to cross-sectional end-of-trial assessments. It is suggested that nonlinear random effects models for longitudinal trajectories are particularly suitable in a delirium context.
It is hoped that the methods described, and nonlinear models in particular, will play a part in convincing analyses of future delirium research.
Journal of psychosomatic research 09/2012; 73(3):197-204. DOI:10.1016/j.jpsychores.2012.06.002 · 2.74 Impact Factor
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