Sertindole versus Risperidone safety outcome study: a randomised, partially-blinded, parallel-group, active-controlled, post-marketing study

undbeck SA0 个研究点目标入组 10,000 人开始时间: 2005年4月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•. 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.

发起方

undbeck SA