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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Asenapine 2.5 mg BID

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

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

Placebo Olanzapine

Intervention Type DRUG

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.

Asenapine 5 mg BID

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

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

Placebo Olanzapine

Intervention Type DRUG

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.

Olanzapine 15 mg QD

Group Type ACTIVE_COMPARATOR

Placebo Asenapine

Intervention Type DRUG

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

Olanzapine

Intervention Type DRUG

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.

Placebo Olanzapine

Intervention Type DRUG

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.

Placebo switched to Asenapine 2.5 mg BID

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

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

Placebo Olanzapine

Intervention Type DRUG

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.

Interventions

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Asenapine

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

Intervention Type DRUG

Placebo Asenapine

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

Intervention Type DRUG

Olanzapine

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.

Intervention Type DRUG

Placebo Olanzapine

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.

Intervention Type DRUG

Other Intervention Names

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Saphris® SCH 900274 Org 5222 Sycrest® Zyprexa

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No