Sertindole versus risperidone safety outcome study: A randomised, partially-blinded, parallel-group, active-controlled, post-marketing study
- Conditions
- 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: 7Level: PsycClassification code 10037175
- Registration Number
- EUCTR2004-000213-19-LT
- Lead Sponsor
- undbeck SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10000
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>? Survival<br><br>Secondary End-points<br>? Cause-specific fatal events (cardiac, suicide, non-suicide),<br>? Hospitalisations, excluding hospitalisations related to the primary psychiatric disease,<br>? Treatment duration<br>
- Secondary Outcome Measures
Name Time Method