Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
With
Meiji Seika Pharma Co., Ltd.
Age
20–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
