Improvement of acute exacerbations of schizophrenia with amisulpride: a comparison with haloperidol

Möller, Hans‐Jürgen; Boyer, Patrice; Fleurot, O.; Rein, W.

doi:10.1007/s002130050361

Cited by 128 publications

(65 citation statements)

References 22 publications

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“…Sometimes the p-values changed quite abruptly from one cutoff to the next higher one. For example, in Möller et al (1997) the p-value of the cutoff 'at least 40% BPRS reduction' was only 0.24, whereas the cutoff 'at least 50% BPRS reduction' showed a significant difference between groups with p ¼ 0.03. Likewise, in Puech et al (1998) the p-value at the 'at least 30%' cutoff was 0.0095, whereas at the 'at least 50%' cutoff it was 0.37.…”

Section: Statistical Measures Resulting From the Use Of Different Cutmentioning

confidence: 92%

“…Figure 2 showing the absolute RRD is consistent with the heterogeneity found for the p-values. For example, in Möller et al (1997) the absolute RRD at the 60% cutoff was 19%, whereas at the 40% cutoff it was only 9%. Or in Sèchter et al (2002) the RRD at the 50% cutoff was 6%, whereas at the 60% cutoff it was À1% in favor of risperidone.…”

Section: Statistical Measures Resulting From the Use Of Different Cutmentioning

confidence: 97%

“…Each trial included participants with schizophrenia or schizophreniform disorder according to DSM-III-R or DSM-IV (American Psychiatric Association, 1987. Four studies compared amisulpride with haloperidol (Möller et al, 1997;Carrière et al, 2000;Puech et al, 1998;Colonna et al, 2000), one with flupenthixol (Wetzel et al, 1998), and two with risperidone (Sèchter et al, 2002;Peuskens et al, 1999). With one exception (Carrière et al, 2000), all studies required various minimum scores as eligibility criteria to assure that the participants had florid positive symptoms.…”

Section: The Databasementioning

confidence: 99%

See 2 more Smart Citations

Defining ‘Response’ in Antipsychotic Drug Trials: Recommendations for the Use of Scale-Derived Cutoffs

Leucht

Davis

Engel

et al. 2007

Neuropsychopharmacol

179

105

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Scale-derived cutoff points are frequently used to define 'response' in antipsychotic drug trials. This procedure is useful, because responder rates can be understood more intuitively than a difference in means of rating scales. As various definitions of response have been used, we examined original participant data to assess whether the choice of the Brief Psychiatric Rating Scale-based response cutoff had an impact on the results of seven (n ¼ 1870) antipsychotic drug trials in schizophrenia. We also analyzed whether the chronicity of the illness has an impact on the question of which cutoff is most sensitive in detecting differences between drugs. The results in terms of p-values and response rate differences varied substantially in dependence on the cutoff chosen. The use of response rate ratios attenuated the variability. In contrast to a widely held belief, low response cutoffs were not more sensitive in detecting differences between drugs than higher cutoffs. In more chronic, less responsive participants, there was a trend for higher cutoffs to be less sensitive in detecting differences between drugs than lower ones. The results of clinical trials depend considerably on the response cutoff chosen. Therefore, the cutoff should never be chosen post hoc, a large range of cutoffs should be presented and the a priori choice of the primary cutoff should be based on clinical relevance. The use of ratios rather than differences attenuates the variability. Cutoffs need to be calculated on the basis of 0-6 rather than on 1-7 scoring systems. We suggest a table presenting responder rates in 25 percent steps covering the whole range up to 100% reduction from baseline, which could be displayed together with recently presented criteria for remission.

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Section: Statistical Measures Resulting From the Use Of Different Cutmentioning

confidence: 92%

Section: Statistical Measures Resulting From the Use Of Different Cutmentioning

confidence: 97%

Section: The Databasementioning

confidence: 99%

See 1 more Smart Citation

Defining ‘Response’ in Antipsychotic Drug Trials: Recommendations for the Use of Scale-Derived Cutoffs

Leucht

Davis

Engel

et al. 2007

Neuropsychopharmacol

179

105

View full text Add to dashboard Cite

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“…27 , NO . 6 patients with acute exacerbations of schizophrenia have shown that amisulpride is as effective as haloperidol and flupenthixol in treating positive symptoms (Möller et al 1997;Puech et al 1998;Wetzel et al 1998) with additional effects on negative symptoms compared with haloperidol (Möller et al 1997). Amisulpride significantly reduces negative symptoms in patients with chronic schizophrenia presenting with enduring predominant negative symptoms (Boyer et al 1995;Loo et al 1997;Danion et al 1999) and in neuroleptic naive mainly negative schizophrenics at the onset of the disorder (Paillère-Martinot et al 1995).…”

mentioning

confidence: 99%

Amisulpride vs. Risperidone in Chronic Schizophrenia Results of a 6-month Double-blind Study

Sechter

Fleurot

Rein

et al. 2002

Neuropsychopharmacology

106

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Schizophrenia is a chronic and disabling disorder with a lifetime prevalence of approximately 1% (American Psychiatric Association 1994). It results in significant long-term functional handicap, severely impairs the quality of life of both the patient and the caregivers and places a considerable financial burden on society.The clinical efficacy of amisulpride against acute psychotic symptoms at high doses (400-800 mg/day) and prominent negative symptoms at low doses (50-300 mg/day) may be explained by its preferential affinity for pre-synaptic dopaminergic D 2 and D 3 autoreceptor subtypes at low doses, while higher doses result in predominant antagonism of post-synaptic dopamine receptors (Perrault et al. 1997;Schoemaker et al. 1997). It also shows selectivity for dopamine receptors in limbic and hippocampal structures, rather than striatal structures, thus suggesting a lower propensity to induce extrapyramidal effects than seen with the classical antipsychotics (Perrault et al. 1997). Studies in

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“…The BPRS database (see Table 1) was composed of original patient data from seven randomized controlled studies that compared amisulpride (Möller et al, 1997;Peuskens et al, 1999;Wetzel et al, 1998;Puech et al, 1998;Colonna et al, 2000;Carrière et al, 2000) or olanzapine (Beasley et al, 1996b), with other antipsychotics and/or placebo. All of the latter studies used the original BPRS (1-7 scale); the BPRS was not derived from the PANSS.…”

Section: The Databasesmentioning

confidence: 99%

Linking the PANSS, BPRS, and CGI: Clinical Implications

Leucht

Kane

Etschel

et al. 2006

Neuropsychopharmacol

257

172

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To understand what given scores of the Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) mean from a clinical point of view is important for the translation of research results into practice. We therefore (a) compared the absolute change of the BPRS/PANSS with the Clinical Global Impressions Ratings (CGI) -improvement score and the change of the CGI severity score, (b) analyzed whether the severity of illness at baseline had an impact on the latter association, and (c) attempted to replicate previous BPRS findings using a completely different data set based upon the PANSS-derived BPRS. The method used was equipercentile linking of BPRS and CGI ratings from 14 drug trials in acutely ill patients with schizophrenia (n ¼ 5970). An absolute reduction of the BPRS/PANSS by approximately 10/15 points corresponded to a CGI change of 'minimally improved' and to a change of the CGI severity score by one severity step. However, the latter associations depended on the severity of symptoms at baseline. Less severely ill patients required less BPRS/PANSS total score reduction to achieve the same CGI-improvement score than more severely ill patients. This effect of initial severity was attenuated using percentage rather than absolute BPRS/PANSS reduction scores.The linking analysis between the absolute BPRS/PANSS reduction and the CGI may have an implication for the interpretation of efficacy differences found in clinical trials, and for sample size estimations. Clinicians seem to base CGI ratings on relative change rather than on absolute change of symptoms.

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Improvement of acute exacerbations of schizophrenia with amisulpride: a comparison with haloperidol

Cited by 128 publications

References 22 publications

Defining ‘Response’ in Antipsychotic Drug Trials: Recommendations for the Use of Scale-Derived Cutoffs

Defining ‘Response’ in Antipsychotic Drug Trials: Recommendations for the Use of Scale-Derived Cutoffs

Amisulpride vs. Risperidone in Chronic Schizophrenia Results of a 6-month Double-blind Study

Linking the PANSS, BPRS, and CGI: Clinical Implications

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