Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)

Organon and Co187 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

187

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completed the short-term 041023 trial (NCT00156104) * Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial * Sign a written informed consent for the 041513 trial. * Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator Exclusion Criteria: * CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic) * Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation * Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial * Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.

Outcomes

Primary Outcomes

Loss of Effect Over Time

Loss of effect in subjects who had \>=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.

Time frame: Throughout the 52 weeks of the trial.

Median Survival Time of Effect

Kaplan-Meier estimate of median time to loss of effect in subjects who had \>=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.

Time frame: 52 Weeks