Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Status:
Completed
Trial end date:
2015-04-22
Target enrollment:
Participant gender:
Summary
This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in
participants with schizophrenia. The first six weeks of the study will be double-blind and
the remainder of the study will be open label. Participants in this study consist of
participants who have completed the preceding short-term study (P06124 [NCT01098110]), who
meet the inclusion criteria and wish to continue receiving study drug, and whom the
investigators have deemed eligible for study participation. Participants who were on placebo
twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg
asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after
week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg
BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or
asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will
be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After
re-randomization, drug will be administered open-label for 46 weeks. During this period dose
is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and
tolerability.