Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

NCT00856583 | Completed Phase 3 Results DMC

• 2 other identifiers: 998242004-000213-19
• Study Type: interventional
• Target: 9,809
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

  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 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

  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 Outcomes (10)

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

  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

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

  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

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

  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

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

  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

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

  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

Study Arms (2)

Sertindole

EXPERIMENTAL

Normally in the range of 4 to 20 mg/day

Drug: Sertindole

Risperidone

ACTIVE COMPARATOR

Normally in the range of 2 to 8 mg/day

Drug: Risperidone

Interventions

Sertindole DRUG

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

Also known as: Serdolect

Sertindole

Risperidone DRUG

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

Also known as: Risperdal

Risperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (5)

• 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.

  PMID: 18384186 RESULT

• 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.

  PMID: 20384598 RESULT

• 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.

  PMID: 20926264 RESULT

• 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.

  PMID: 20820795 RESULT

• 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.

  PMID: 20732794 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: July 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 19, 2011
• Results First Posted: August 1, 2011

Record last verified: 2011-08