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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
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
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
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.
Forest Investigative Site 2001
Austin, Texas, United States
Change in Weight From Baseline to Day 182
Time frame: Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)
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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.