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Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use (SCoP)
This study has been completed.
Sponsor:
H. Lundbeck A/S
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856583
First received: March 5, 2009
Last updated: August 18, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: Sertindole Drug: Risperidone | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Number of Participants With All-cause Mortality [ 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 ]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 [ 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 ]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 [ 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 ]
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 [ 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 ]
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 [ 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 ]
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 [ 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 ]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 [ 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 ]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 [ 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 ]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 [ 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 ]
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 [ 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 ]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 [ 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 ]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 [ 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 ]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
| Enrollment: | 9809 |
| Study Start Date: | July 2002 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sertindole
Normally in the range of 4 to 20 mg/day
|
Drug: Sertindole
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
Other Name: Serdolect
|
|
Active Comparator: Risperidone
Normally in the range of 2 to 8 mg/day
|
Drug: Risperidone
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
Other Name: Risperdal
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00856583
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856583
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
Publications:
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00856583 History of Changes |
| Other Study ID Numbers: |
99824 2004-000213-19 ( EudraCT Number ) |
| Study First Received: | March 5, 2009 |
| Results First Received: | May 4, 2011 |
| Last Updated: | August 18, 2011 |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Sertindole Risperidone Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on June 23, 2017