Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)
- Registration Number
- NCT00151424
- Lead Sponsor
- Organon and Co
- Brief Summary
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.
Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- Currently suffering from an acute exacerbation of schizophrenia.
- Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 asenapine asenapine 5-10mg BID 3 Olanzapine olanzapine 10-20 mg QD 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline Screen, baseline, days 4, 7, 14, 21, 28, 35, 42 A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).
- Secondary Outcome Measures
Name Time Method Anxiety Baseline, day 42 This was not a prespecified key secondary outcome
Readiness to discharge, at scheduled assessments and endpoint from baseline Baseline up to day 14 This was not a prespecified key secondary outcome
Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores Screen, baseline, Days 4,7,14,21,28,35,42 This was not a prespecified key secondary outcome
Quality of life and patient functionality Baseline, day 42 This was not a prespecified key secondary outcome
Vital signs Baseline, Days ,14,21,28,42 This was not a prespecified key secondary outcome
Weight Baseline, Days 14,,28,,42 This was not a prespecified key secondary outcome
Serious adverse events (SAEs) up to 30 days after endpoint Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint This was not a prespecified key secondary outcome
Adverse events (including serious adverse events) Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint This was not a prespecified key secondary outcome
Clinical Global Impression Improvement (CGI-I) scores Days 4,7,14,21,28,35,42 This was not a prespecified key secondary outcome
Laboratory parameters Baseline, Days 14,,28,,42 This was not a prespecified key secondary outcome
Electrocardiograms (ECGs) Baseline, Days ,14, 28, 42 This was not a prespecified key secondary outcome
Neurocognition and cognitive functioning Baseline , day 42 This was not a prespecified key secondary outcome
Suicidal thinking Baseline, day 42 This was not a prespecified key secondary outcome
Extrapyramidal symptoms Baseline, Days 4,7,14,21,28,35,42 This was not a prespecified key secondary outcome