Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Risperidone; Sertindole

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