Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
- Registration Number
- NCT00763438
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Participation in the previous SCoP study, 99824
- Still fulfils the EU SPC requirements for Sertindole
- Withdrawn before the end of the SCoP study, 99824
- Become homeless
- Participation in another clinical trial at the same time
- Unlikely to comply with the clinical study protocol or is unsuitable for any reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sertindole Sertindole -
- Primary Outcome Measures
Name Time Method All serious adverse events reported; visits scheduled every 3 months Every 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FR002
🇫🇷Allonnes, France