Schizophrenia
Conditions
Keywords
Schizophrenia, Sertindole, Safety study
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.
Interventions
DRUGSertindole
Flexible dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in the previous SCoP study, 99824 * Still fulfils the EU SPC requirements for Sertindole
Exclusion criteria
* Withdrawn before the end of the SCoP study, 99824 * Become homeless * Participation in another clinical trial at the same time * Unlikely to comply with the clinical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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All serious adverse events reported; visits scheduled every 3 months | Every 3 months |
Countries
France
Outcome results
None listed