Phase 3 N=9,809 Randomized Prevention

Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00856583 ↗

Enrolled (actual)

9,809

Serious AEs

4.9%

Results posted

Aug 2011

Primary outcome: Primary: Number of Participants With All-cause Mortality — 64; 61; 40; 44 participants — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sertindole (Drug); Risperidone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With All-cause Mortality	64; 61; 40; 44	0.05
PRIMARY Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation	10; 6	0.29
SECONDARY Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC	31; 12	0.0022 sig
SECONDARY Cause-specific Mortality: Number of Participants With Completed Suicides - ISC	14; 21	0.34
SECONDARY Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC	19; 28	0.26
SECONDARY Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA	17; 8	0.081
SECONDARY Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA	13; 21	0.24
SECONDARY Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA	34; 32	0.59
SECONDARY Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC	68; 76	0.65
SECONDARY Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA	43; 65	0.044 sig
SECONDARY Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease	174; 149	0.040 sig
SECONDARY Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure	3136; 2597	<0.0001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00856583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.