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Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use (SCoP)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sertindole
Risperidone
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
  • The patient has been diagnosed with schizophrenia
  • Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
  • The patient is at least 18 years of age
  • The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

  • The last treatment taken by the patient was sertindole or risperidone
  • The patient has never previously received any antipsychotic drug therapy
  • The patient has contraindications to treatment with either sertindole or risperidone
  • In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
  • The patient is homeless
  • The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
  • The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sertindole

    Risperidone

    Arm Description

    Normally in the range of 4 to 20 mg/day

    Normally in the range of 2 to 8 mg/day

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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.
    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.
    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.
    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
    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
    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
    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.
    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
    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
    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

    Full Information

    First Posted
    March 5, 2009
    Last Updated
    August 18, 2011
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00856583
    Brief Title
    Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
    Acronym
    SCoP
    Official Title
    Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    H. Lundbeck A/S

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.
    Detailed Description
    The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9809 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sertindole
    Arm Type
    Experimental
    Arm Description
    Normally in the range of 4 to 20 mg/day
    Arm Title
    Risperidone
    Arm Type
    Active Comparator
    Arm Description
    Normally in the range of 2 to 8 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Sertindole
    Other Intervention Name(s)
    Serdolect
    Intervention Description
    Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Other Intervention Name(s)
    Risperdal
    Intervention Description
    Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day
    Primary Outcome Measure Information:
    Title
    Number of Participants With All-cause Mortality
    Description
    The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively
    Time Frame
    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
    Title
    Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation
    Description
    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
    Time Frame
    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
    Secondary Outcome Measure Information:
    Title
    Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC
    Description
    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.
    Time Frame
    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
    Title
    Cause-specific Mortality: Number of Participants With Completed Suicides - ISC
    Description
    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.
    Time Frame
    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
    Title
    Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC
    Description
    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.
    Time Frame
    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
    Title
    Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA
    Description
    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
    Time Frame
    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
    Title
    Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA
    Description
    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
    Time Frame
    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
    Title
    Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA
    Description
    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
    Time Frame
    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
    Title
    Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC
    Description
    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.
    Time Frame
    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
    Title
    Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA
    Description
    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
    Time Frame
    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
    Title
    Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease
    Description
    The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period
    Time Frame
    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
    Title
    Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure
    Description
    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
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form The patient has been diagnosed with schizophrenia Based on the patient's clinical status, new or change of antipsychotic treatment is indicated The patient is at least 18 years of age The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied Exclusion Criteria: The last treatment taken by the patient was sertindole or risperidone The patient has never previously received any antipsychotic drug therapy The patient has contraindications to treatment with either sertindole or risperidone In addition to sertindole/risperidone, treatment with another antipsychotic is indicated The patient is homeless The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824 The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Email contact via H. Lundbeck A/S
    Organizational Affiliation
    LundbeckClinicalTrials@lundbeck.com
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18384186
    Citation
    Peuskens J, Tanghoj P, Mittoux A; Sertindole Cohort. The Sertindole Cohort Prospective (SCoP) study: rationale, design and methodology. Pharmacoepidemiol Drug Saf. 2008 May;17(5):425-33. doi: 10.1002/pds.1594.
    Results Reference
    result
    PubMed Identifier
    20384598
    Citation
    Thomas SH, Drici MD, Hall GC, Crocq MA, Everitt B, Lader MH, Le Jeunne C, Naber D, Priori S, Sturkenboom M, Thibaut F, Peuskens J, Mittoux A, Tanghoj P, Toumi M, Moore ND, Mann RD. Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). Acta Psychiatr Scand. 2010 Nov;122(5):345-55. doi: 10.1111/j.1600-0447.2010.01563.x.
    Results Reference
    result
    PubMed Identifier
    20926264
    Citation
    Crocq MA, Naber D, Lader MH, Thibaut F, Drici M, Everitt B, Hall GC, Le Jeunne C, Mittoux A, Peuskens J, Priori S, Sturkenboom M, Thomas SH, Tanghoj P, Toumi M, Mann R, Moore ND. Suicide attempts in a prospective cohort of patients with schizophrenia treated with sertindole or risperidone. Eur Neuropsychopharmacol. 2010 Dec;20(12):829-38. doi: 10.1016/j.euroneuro.2010.09.001.
    Results Reference
    result
    PubMed Identifier
    20820795
    Citation
    De Hert M, Mittoux A, He Y, Peuskens J. Metabolic parameters in the short- and long-term treatment of schizophrenia with sertindole or risperidone. Eur Arch Psychiatry Clin Neurosci. 2011 Jun;261(4):231-9. doi: 10.1007/s00406-010-0142-x. Epub 2010 Sep 5.
    Results Reference
    result
    PubMed Identifier
    20732794
    Citation
    De Hert M, Mittoux A, He Y, Peuskens J. A head-to-head comparison of sertindole and risperidone on metabolic parameters. Schizophr Res. 2010 Nov;123(2-3):276-7. doi: 10.1016/j.schres.2010.07.030. Epub 2010 Aug 21. No abstract available.
    Results Reference
    result

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    Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

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