ong-term efficacy and safety evaluation of asenapine (10-20 mg/day) in subjects with schizophrenia or schizoaffective disorder, in a multicenter trial using olanzapine (10-20 mg/day) as a control. - N/A
- Conditions
- schizophrenia or schizoaffective disorderMedDRA version: 7.0 Level: HLGT Classification code 10039628
- Registration Number
- EUCTR2004-001376-39-CZ
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
To be considered for inclusion into this trial subjects must have completed the ACTAMESA study and provide written informed consent (or verbal witnessed informed consent for illiterate subjects in South-Africa) after the scope and nature of the extension study have been explained to them.
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
Subjects will be excluded from further consideration if they do not fulfill the inclusion criteria, or if they either suffer from a medical condition or require concomitant treatment that will obscure trial results or will put the patient at increased risk for treatment failure or unacceptable adverse events. It is left to the discretion of the investigators, whether subjects have to be excluded from further treatment because of such reasons.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method