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

Organon

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Asenapine; Drug: Haloperidol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00156065

41513

Hera ;

P05785

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

187 participants in 3 patient groups

Haloperidol/Haloperidol

Active Comparator group

Description:

Haloperidol in original study (NCT00156104) and in current long-term extension.

Treatment:

Drug: Haloperidol

Asenapine/Asenapine

Experimental group

Description:

Asenapine in original study and asenapine in current long-term extension.

Treatment:

Drug: Asenapine

Drug: Asenapine

Placebo/Asenapine

Experimental group

Description:

Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52-week trial.

Treatment:

Drug: Asenapine

Drug: Asenapine