Page last updated: 2024-11-03

risperidone and Cardiac Diseases

risperidone has been researched along with Cardiac Diseases in 5 studies

Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.
risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.

Research Excerpts

ExcerptRelevanceReference
"This open-label, rater-blinded, parallel-group study was designed to evaluate noninferiority of paliperidone palmitate (PP), a once-monthly injectable atypical antipsychotic, to once-biweekly risperidone long-acting injectable (RIS-LAI) in adult Chinese patients with acute schizophrenia."9.15A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. ( Gu, N; Li, H; Ning, X; Rui, Q; Xu, H, 2011)
"Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole."6.75Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). ( Crocq, MA; Drici, MD; Everitt, B; Hall, GC; Lader, MH; Le Jeunne, C; Mann, RD; Mittoux, A; Moore, ND; Naber, D; Peuskens, J; Priori, S; Sturkenboom, M; Tanghøj, P; Thibaut, F; Thomas, SH; Toumi, M, 2010)
"This open-label, rater-blinded, parallel-group study was designed to evaluate noninferiority of paliperidone palmitate (PP), a once-monthly injectable atypical antipsychotic, to once-biweekly risperidone long-acting injectable (RIS-LAI) in adult Chinese patients with acute schizophrenia."5.15A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. ( Gu, N; Li, H; Ning, X; Rui, Q; Xu, H, 2011)
"Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole."2.75Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). ( Crocq, MA; Drici, MD; Everitt, B; Hall, GC; Lader, MH; Le Jeunne, C; Mann, RD; Mittoux, A; Moore, ND; Naber, D; Peuskens, J; Priori, S; Sturkenboom, M; Tanghøj, P; Thibaut, F; Thomas, SH; Toumi, M, 2010)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (40.00)29.6817
2010's3 (60.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Thomas, SH1
Drici, MD1
Hall, GC1
Crocq, MA1
Everitt, B1
Lader, MH1
Le Jeunne, C1
Naber, D1
Priori, S1
Sturkenboom, M1
Thibaut, F1
Peuskens, J1
Mittoux, A1
Tanghøj, P1
Toumi, M1
Moore, ND1
Mann, RD1
Correll, CU1
Nielsen, J1
Li, H1
Rui, Q1
Ning, X1
Xu, H1
Gu, N1
Silke, B1
Campbell, C1
King, DJ1
Vaillant, F1
Turrel, F1
Bost, M1
Bricca, G1
Descotes, J1
Bui-Xuan, B1
Tabib, A1
Manati, W1
Timour, Q1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study[NCT00856583]Phase 39,809 participants (Actual)Interventional2002-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC

"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide." (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole31
Risperidone12

Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA

The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole17
Risperidone8

Cause-specific Mortality: Number of Participants With Completed Suicides - ISC

"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide." (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole14
Risperidone21

Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA

The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole13
Risperidone21

Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC

"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide." (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole19
Risperidone28

Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA

The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole34
Risperidone32

Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure

The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole3136
Risperidone2597

Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease

The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole174
Risperidone149

Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC

"The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide." (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole68
Risperidone76

Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA

The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole43
Risperidone65

Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation

Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

Interventionparticipants (Number)
Sertindole10
Risperidone6

Number of Participants With All-cause Mortality

The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively (NCT00856583)
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months

,
Interventionparticipants (Number)
Number of deaths (WRT+30 days)Number of deaths (ORT)
Risperidone6144
Sertindole6440

Trials

3 trials available for risperidone and Cardiac Diseases

ArticleYear
Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP).
    Acta psychiatrica Scandinavica, 2010, Volume: 122, Issue:5

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antipsychotic Agents; Arrhythmias, Cardiac; Female; Hear

2010
A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia.
    Progress in neuro-psychopharmacology & biological psychiatry, 2011, Jun-01, Volume: 35, Issue:4

    Topics: Adolescent; Adult; Antipsychotic Agents; Data Interpretation, Statistical; Delayed-Action Preparatio

2011
The potential cardiotoxicity of antipsychotic drugs as assessed by heart rate variability.
    Journal of psychopharmacology (Oxford, England), 2002, Volume: 16, Issue:4

    Topics: Adult; Antipsychotic Agents; Benzodiazepines; Conscious Sedation; Double-Blind Method; Heart Disease

2002

Other Studies

2 other studies available for risperidone and Cardiac Diseases

ArticleYear
Antipsychotic-associated all-cause and cardiac mortality: what should we worry about and how should the risk be assessed?
    Acta psychiatrica Scandinavica, 2010, Volume: 122, Issue:5

    Topics: Antipsychotic Agents; Data Interpretation, Statistical; Heart Diseases; Humans; Imidazoles; Indoles;

2010
Role of selenium in heart lesions produced by neuroleptics in the rabbit.
    Journal of applied toxicology : JAT, 2008, Volume: 28, Issue:2

    Topics: Animals; Antipsychotic Agents; Down-Regulation; Female; Heart Diseases; Injections, Intramuscular; K

2008