Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

Condition(s) targeted: Schizophrenia

Intervention: Sertindole (Drug); Risperidone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

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.

Official title: Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Number of Participants With All-cause Mortality

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

Secondary outcome:

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

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

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

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

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

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

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

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

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

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: July 2002
Last updated: August 18, 2011