Schizophrenia with predominant, persistent negative symptoms MedDRA version: 7.1 Level: LLT Classification code 10039626
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. sign written informed consent after the scope and nature of the investigation have been explained. Subjects unable or incapable of signing may participate if a legally authorized representative provides consent and the subject affirms their participation; 2. have completed the 25543 trial, and would benefit from continued treatment according to the investigator’s judgment; 3. have demonstrated an acceptable degree of compliance with trial medication in the 25543 trial in the opinion of the investigator; and 4. continue to meet all demographic and procedural inclusion criteria of the 25543 trial upon entry into this extension trial. 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. have an uncontrolled, unstable clinically significant medical condition (e.g., renal, hepatic, endocrine, respiratory, cardiovascular, hematologic, immunologic, cerebrovascular disease, anorexia (body mass index [BMI] 35) or malignancy that may interfere with the interpretation of safety or efficacy evaluations in the opinion of the investigator; 2. have any clinically significant abnormal laboratory, vital sign, physical examination, or ECG findings, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations; 3. have a positive result on the serum pregnancy test or are breastfeeding at end of trial EOT (Day 182 of study 25543)/baseline protocol 25544), or intend to become pregnant during the course of the trial; 4. require high doses of benzodiazepines (=4 mg per day lorazepam or equivalent) 5. have been judged by the principal investigator to be medically non-compliant in the management of their disease; 6. present an imminent risk of self-harm or harm to others; or 7. have a score of 2 on items 7, 10 or 11 on the ISST-modified at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the long-term efficacy and safety of 5-10 mg BID asenapine to that of 5-20 mg QD olanzapine in the treatment of predominant persistent negative symptoms of schizophrenia.;Secondary Objective: Objectives also include the assessment of Quality of Life and patient functionality outcomes.;Primary end point(s): The change at 52 weeks in total score in the Negative Symptom Assessment (NSA) from baseline (Protocol 25543). | — |
Countries
Czech Republic, Finland, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed