At a glance
ClinicalIndex Comparison Record- ✓Completion of the prior short-term 041023 trial (NCT00156104)
- ✓Continued to meet all demographic and procedural inclusion criteria from the short-term trial
- ✓Demonstrated acceptable medication compliance in short-term trials per investigator assessment
- ✓Written informed consent for this trial
- ✕CGI-S (Clinical Global Impressions of Severity) score ≥6 (severely psychotic)
- ✕Adverse events or clinically significant findings that would prohibit continuation
- ✕Medical or psychiatric status exclusions from the short-term 041023 trial
- ✕Medication status exclusions from short-term trial (except antidepressants and mood stabilizers)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Haloperidol Positive Control in Subjects Who Complete Protocol 041023 [NCT00156104]
In Brief
A Phase 3 clinical trial evaluating Haloperidol and Asenapine for Schizophrenia. Completed, enrolled 187 participants.
Detailed 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. The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.
Study Details
Timeline
Interventions
2-8 mg BID
5 or 10 mg BID
5 or 10 mg BID