A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia

John M. Kane, Steven G. Potkin, David G. Daniel, Peter F Buckley

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Objective: The comparative efficacy of second-generation antipsychotics has yet to be fully elucidated in patients with treatment-resistant schizophrenia. The objective of this study was to examine the efficacy and safety of sertindole, compared to risperidone, in this patient population. Method: In this multicenter, phase 3, randomized, double-blind, parallel-group study, only patients with DSM-IV schizophrenia who had failed an adequate antipsychotic treatment within the previous 6 months and who had not responded positively to haloperidol during screening were eligible for enrollment. The primary efficacy variable was change in Positive and Negative Syndrome Scale (PANSS) from baseline to final assessment. Weekly assessments included the PANSS, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), and the Clinical Global Impressions (CGI) scale. The study was conducted between June 1996 and April 1998. Results: Of the 321 patients randomly assigned to double-blind treatment, 217 patients completed the study (sertindole, n/n = 142/216 [66%]; risperidone, n/n = 75/105 [71%]). The main reason for withdrawal in both groups was ineffective therapy. The between-group difference in PANSS total score was not statistically significant and both groups showed improvement, with mean changes of -18.6 in the sertindole group and -20.9 in the risperidone group based on observed cases and -12.0 and -19.0, respectively, based on the last-observation-carried-forward method for imputing missing data. There were no statistically significant differences between the groups in any of the secondary end points: PANSS positive and negative subscales, CGI scores, BPRS total scores and positive symptom subscale scores, and SANS total scores. Patients reported similar levels of adverse events and treatment-emergent adverse events (TEAEs), except for extrapyramidal syndrome-related TEAEs, which were more common in the risperidone-treated group. Prolongation of the QTc interval was observed significantly more frequently with sertindole treatment. Conclusions: Sertindole and risperidone are effective and well-tolerated in patients with treatment-resistant schizophrenia. Sertindole offers an alternative treatment option for refractory patients in Europe given its good EPS profile, favorable metabolic profile, and comparable efficacy to risperidone.

Original languageEnglish (US)
Pages (from-to)194-204
Number of pages11
JournalJournal of Clinical Psychiatry
Volume72
Issue number2
DOIs
StatePublished - Feb 1 2011

Fingerprint

Risperidone
Double-Blind Method
Schizophrenia
Safety
Brief Psychiatric Rating Scale
Symptom Assessment
Therapeutics
Antipsychotic Agents
sertindole
Metabolome
Haloperidol
Diagnostic and Statistical Manual of Mental Disorders
Observation

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia. / Kane, John M.; Potkin, Steven G.; Daniel, David G.; Buckley, Peter F.

In: Journal of Clinical Psychiatry, Vol. 72, No. 2, 01.02.2011, p. 194-204.

Research output: Contribution to journalArticle

Kane, John M. ; Potkin, Steven G. ; Daniel, David G. ; Buckley, Peter F. / A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia. In: Journal of Clinical Psychiatry. 2011 ; Vol. 72, No. 2. pp. 194-204.
@article{e46681fda57e47b0b8ee1b837eb239d4,
title = "A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia",
abstract = "Objective: The comparative efficacy of second-generation antipsychotics has yet to be fully elucidated in patients with treatment-resistant schizophrenia. The objective of this study was to examine the efficacy and safety of sertindole, compared to risperidone, in this patient population. Method: In this multicenter, phase 3, randomized, double-blind, parallel-group study, only patients with DSM-IV schizophrenia who had failed an adequate antipsychotic treatment within the previous 6 months and who had not responded positively to haloperidol during screening were eligible for enrollment. The primary efficacy variable was change in Positive and Negative Syndrome Scale (PANSS) from baseline to final assessment. Weekly assessments included the PANSS, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), and the Clinical Global Impressions (CGI) scale. The study was conducted between June 1996 and April 1998. Results: Of the 321 patients randomly assigned to double-blind treatment, 217 patients completed the study (sertindole, n/n = 142/216 [66{\%}]; risperidone, n/n = 75/105 [71{\%}]). The main reason for withdrawal in both groups was ineffective therapy. The between-group difference in PANSS total score was not statistically significant and both groups showed improvement, with mean changes of -18.6 in the sertindole group and -20.9 in the risperidone group based on observed cases and -12.0 and -19.0, respectively, based on the last-observation-carried-forward method for imputing missing data. There were no statistically significant differences between the groups in any of the secondary end points: PANSS positive and negative subscales, CGI scores, BPRS total scores and positive symptom subscale scores, and SANS total scores. Patients reported similar levels of adverse events and treatment-emergent adverse events (TEAEs), except for extrapyramidal syndrome-related TEAEs, which were more common in the risperidone-treated group. Prolongation of the QTc interval was observed significantly more frequently with sertindole treatment. Conclusions: Sertindole and risperidone are effective and well-tolerated in patients with treatment-resistant schizophrenia. Sertindole offers an alternative treatment option for refractory patients in Europe given its good EPS profile, favorable metabolic profile, and comparable efficacy to risperidone.",
author = "Kane, {John M.} and Potkin, {Steven G.} and Daniel, {David G.} and Buckley, {Peter F}",
year = "2011",
month = "2",
day = "1",
doi = "10.4088/JCP.07m03733yel",
language = "English (US)",
volume = "72",
pages = "194--204",
journal = "Journal of Clinical Psychiatry",
issn = "0160-6689",
publisher = "Physicians Postgraduate Press Inc.",
number = "2",

}

TY - JOUR

T1 - A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia

AU - Kane, John M.

AU - Potkin, Steven G.

AU - Daniel, David G.

AU - Buckley, Peter F

PY - 2011/2/1

Y1 - 2011/2/1

N2 - Objective: The comparative efficacy of second-generation antipsychotics has yet to be fully elucidated in patients with treatment-resistant schizophrenia. The objective of this study was to examine the efficacy and safety of sertindole, compared to risperidone, in this patient population. Method: In this multicenter, phase 3, randomized, double-blind, parallel-group study, only patients with DSM-IV schizophrenia who had failed an adequate antipsychotic treatment within the previous 6 months and who had not responded positively to haloperidol during screening were eligible for enrollment. The primary efficacy variable was change in Positive and Negative Syndrome Scale (PANSS) from baseline to final assessment. Weekly assessments included the PANSS, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), and the Clinical Global Impressions (CGI) scale. The study was conducted between June 1996 and April 1998. Results: Of the 321 patients randomly assigned to double-blind treatment, 217 patients completed the study (sertindole, n/n = 142/216 [66%]; risperidone, n/n = 75/105 [71%]). The main reason for withdrawal in both groups was ineffective therapy. The between-group difference in PANSS total score was not statistically significant and both groups showed improvement, with mean changes of -18.6 in the sertindole group and -20.9 in the risperidone group based on observed cases and -12.0 and -19.0, respectively, based on the last-observation-carried-forward method for imputing missing data. There were no statistically significant differences between the groups in any of the secondary end points: PANSS positive and negative subscales, CGI scores, BPRS total scores and positive symptom subscale scores, and SANS total scores. Patients reported similar levels of adverse events and treatment-emergent adverse events (TEAEs), except for extrapyramidal syndrome-related TEAEs, which were more common in the risperidone-treated group. Prolongation of the QTc interval was observed significantly more frequently with sertindole treatment. Conclusions: Sertindole and risperidone are effective and well-tolerated in patients with treatment-resistant schizophrenia. Sertindole offers an alternative treatment option for refractory patients in Europe given its good EPS profile, favorable metabolic profile, and comparable efficacy to risperidone.

AB - Objective: The comparative efficacy of second-generation antipsychotics has yet to be fully elucidated in patients with treatment-resistant schizophrenia. The objective of this study was to examine the efficacy and safety of sertindole, compared to risperidone, in this patient population. Method: In this multicenter, phase 3, randomized, double-blind, parallel-group study, only patients with DSM-IV schizophrenia who had failed an adequate antipsychotic treatment within the previous 6 months and who had not responded positively to haloperidol during screening were eligible for enrollment. The primary efficacy variable was change in Positive and Negative Syndrome Scale (PANSS) from baseline to final assessment. Weekly assessments included the PANSS, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), and the Clinical Global Impressions (CGI) scale. The study was conducted between June 1996 and April 1998. Results: Of the 321 patients randomly assigned to double-blind treatment, 217 patients completed the study (sertindole, n/n = 142/216 [66%]; risperidone, n/n = 75/105 [71%]). The main reason for withdrawal in both groups was ineffective therapy. The between-group difference in PANSS total score was not statistically significant and both groups showed improvement, with mean changes of -18.6 in the sertindole group and -20.9 in the risperidone group based on observed cases and -12.0 and -19.0, respectively, based on the last-observation-carried-forward method for imputing missing data. There were no statistically significant differences between the groups in any of the secondary end points: PANSS positive and negative subscales, CGI scores, BPRS total scores and positive symptom subscale scores, and SANS total scores. Patients reported similar levels of adverse events and treatment-emergent adverse events (TEAEs), except for extrapyramidal syndrome-related TEAEs, which were more common in the risperidone-treated group. Prolongation of the QTc interval was observed significantly more frequently with sertindole treatment. Conclusions: Sertindole and risperidone are effective and well-tolerated in patients with treatment-resistant schizophrenia. Sertindole offers an alternative treatment option for refractory patients in Europe given its good EPS profile, favorable metabolic profile, and comparable efficacy to risperidone.

UR - http://www.scopus.com/inward/record.url?scp=79952000508&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952000508&partnerID=8YFLogxK

U2 - 10.4088/JCP.07m03733yel

DO - 10.4088/JCP.07m03733yel

M3 - Article

C2 - 20673553

AN - SCOPUS:79952000508

VL - 72

SP - 194

EP - 204

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

SN - 0160-6689

IS - 2

ER -