Schizophrenic patients most recently treated with antipsychotics other than sertindole or risperidone, requiring a new prescription for an antipsychotic, and without any contraindications for either risperidone or sertindole. MedDRA version: 7 Level: Psyc Classification code 10037175
Conditions
Interventions
Trade Name: Sertindole 4 mg
Sertindole 12 mg
Sertindole 16 mg
Sertindole 20 mg
Product Name: Sertindole
Product Code: Lu 23-174
Pharmaceutical Form: Tablet
Trade Name: Risperidonum 1mg
Risperidonum 2
Sponsors
Lundbeck SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has signed the Informed Consent Form or if he/she is not able to sign it (following the ICH GCP guidelines, 4.8 and Helsinki Declaration, 24), patient’s legal representative has signed the Informed Consent Form, 2. The patient is diagnosed with schizophrenia, 3. Based on the patient’s clinical status, new antipsychotic treatment is indicated, 4. The patient is at least 18 years of age, 5. The patient meets the criteria set out in the national SPC for both sertindole and risperidone. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The last treatment taken by the patient is sertindole or risperidone, 2. The patient has never previously received any antipsychotic drug therapy, 3. The patient has contraindications to treatment with one of the both study drugs, 4. In addition to sertindole/risperidone, treatment with another antipsychotic is indicated, 5. The patient is homeless, 6. The patient has previously been included in one of the two Lundbeck post marketing studies (99823 or 99824), 7. The patient, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety of sertindole with that of risperidone under normal conditions of use.;Secondary Objective: ;Primary end point(s): First Primary End-point ? Survival Secondary End-points ? Cause-specific fatal events (cardiac, suicide, non-suicide), ? Hospitalisations, excluding hospitalisations related to the primary psychiatric disease, ? Treatment duration | — |
Countries
Latvia, Lithuania
Outcome results
None listed