Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

Study Overview
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Brief Summary
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Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.

Official Title
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A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Asenapine
* Drug: Placebo Asenapine
* Drug: Olanzapine
* Drug: Placebo Olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment Exclusion Criteria: Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asenapine 2.5 mg BID<br> | Drug: Asenapine<br>* 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening<br>* Other names: Sycrest®;Drug: Placebo Olanzapine<br>* 15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.<br>|
| Experimental: Asenapine 5 mg BID<br> | Drug: Asenapine<br>* 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening<br>* Other names: Sycrest®;Drug: Placebo Olanzapine<br>* 15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.<br>|
| Active Comparator: Olanzapine 15 mg QD<br> | Drug: Placebo Asenapine<br>* 2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening<br>Drug: Olanzapine<br>* 15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.<br>* Other names: Zyprexa;Drug: Placebo Olanzapine<br>* 15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.<br>|
| Experimental: Placebo switched to Asenapine 2.5 mg BID<br> | Drug: Asenapine<br>* 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening<br>* Other names: Sycrest®;Drug: Placebo Olanzapine<br>* 15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight From Baseline to Day 182 |  | Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension) |