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

NCT ID: NCT00156065

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-10-31

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Haloperidol/Haloperidol

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

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

2-8 mg BID

Asenapine/Asenapine

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

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

5 or 10 mg BID

Placebo/Asenapine

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.

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

5 or 10 mg BID

Interventions

Haloperidol

2-8 mg BID

Intervention Type: DRUG

Asenapine

5 or 10 mg BID

Intervention Type: DRUG

Asenapine

5 or 10 mg BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Completed the short-term 041023 trial (NCT00156104)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Hera;

Identifier Type: -

Identifier Source: secondary_id

41513

Identifier Type: -

Identifier Source: secondary_id

P05785

Identifier Type: -

Identifier Source: org_study_id