Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

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

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.

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.

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