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

Condition(s) targeted: Schizophrenia

Intervention: Haloperidol (Drug); Asenapine (Drug); Asenapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Official title: 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]

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Loss of Effect Over Time

Median Survival Time of Effect

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: September 2005
Last updated: October 20, 2014