The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,225
Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Time frame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
Changes in PANSS subscale scores and Marder factor scores
Time frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Changes in CGI-S
Time frame: At each assessment time point from baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Time frame: At weeks 8, 20, 28, 36, 44 and endpoint
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Time frame: At weeks 6, 28 and endpoint
Resource utilization (as measured by frequency and length of hospital stay)
Time frame: During the study period
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Time frame: At endpoint
Population kinetics
Time frame: Plasma samples at weeks 2 and 6 in comparison with baseline
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Time frame: During the study period
Safety and tolerability: EPS (AIMS, BARS, SARS)
Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Adverse Events
Time frame: continuously and up to 7 days after endpoint
Pregnancy Test
Time frame: At endpoint
Blood Test
Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Weight and vital signs
Time frame: at all assessment time points from baseline
ECGs
Time frame: Weeks 3, 6, 24, and endpoint
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