Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine; Placebo
Intervention description: Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID; Placebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has completed 42-day drug administration in the preceding short-term study
             (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding
             short-term study of markedly improved, moderately improved, or slightly improved), has
             no significant safety problems, and has been judged appropriate for study
             participation by the investigator.

          -  Male and female participants. Women who are of childbearing potential (i.e., not
             surgically sterile or post menopausal for at least 1 year) must use medically
             acceptable birth control. Medically acceptable birth control includes condoms (male or
             female) with or without a spermicidal agent, diaphragm or cervical cap with
             spermicide, medically prescribed IUD, insert or copper-containing IUD,
             hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization
             (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms
             during their participation in the study.

          -  Participant must have been explained the nature of the study by the investigator, and
             be able to provide written consent prior to the conduct of the tests/observation of
             the clinical study.

        Exclusion Criteria:

          -  A participant must not have any clinically significant abnormal laboratory, vital
             sign, physical examination, or electrocardiogram (ECG) findings that, in the
             investigator's opinion, preclude the participant's participation in the study

          -  A participant must not have a positive pregnancy test or be planning to become
             pregnant during the term of the study;

          -  A participant must not receive antipsychotics, antidepressants, mood stabilizers,
             anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are
             dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the
             baseline;

          -  A participant must not be at risk of harming themselves or others, in the
             investigator's opinion;

          -  A participant must not have been determined to be unsuitable by an investigator.