schizophrenia or schizoaffective disorder MedDRA version: 7.0 Level: HLGT Classification code 10039628
Conditions
Interventions
Product Name: Asenapine tablets
Product Code: Org 5222
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Asenapine
CAS Number: 85650-56-2
Current Sponsor code: Org 5222
Other descriptive nam
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the long-term safety and efficacy of asenapine in those subjects who have completed the ACTAMESA trial and who will be continued on trial medication. Olanzapine will be used as a control.;Secondary Objective: ;Primary end point(s): The total score on the Positive and Negative Syndrome Scale (PANSS). | — |
Countries
Germany, Spain
Outcome results
None listed