Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.
Condition or disease
Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participation in the previous SCoP study, 99824
Still fulfils the EU SPC requirements for Sertindole
Withdrawn before the end of the SCoP study, 99824
Participation in another clinical trial at the same time
Unlikely to comply with the clinical study protocol or is unsuitable for any reason