None listed
Conditions
Interventions
ELIGIBLE SUBJECTS MAY ENROLL INTO THIS CONTINUATION STUDY DIRECTLY (OR WITHIN 10 DAYS) AFTER COMPLETING THE EXTENSION PHASE OF A PRIOR LURASIDONE CLINICAL STUDY. SUBJECTS THAT HAVE COMPLETED AN EXTENS
Sponsors
SUNOVION PHARMACEUTICALS INC.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. THE SUBJECT OR LEGAL GUARDIAN PROVIDES WRITTEN INFORMED CONSENT. FOR ELIGIBLE SUBJECTS UNDER AGE 18, VERBAL ASSENT IS ALSO REQUIRED. 2. THE SUBJECT HAS COMPLETED THE EXTENSION PHASE OF A PRIOR LURASIDONE CLINICAL STUDY. ELIGIBLE SUBJECTS MAY ENROLL INTO THIS CONTINUATION STUDY DIRECTLY (OR WITHIN 10 DAYS) AFTER COMPLETING THE EXTENSION PHASE OF A PRIOR LUASIDONE CLINICAL STUDY. SUBJECTS THAT HAVE COMPLETED AN EXTENSION STUDY PRIOR TO THE INITIATION OF THIS PROTOCOL AT THE STUDY SITE MAY PARTICIPATE IN THIS STUDY UP TO 3 MONTHS AFTER COMPLETION OF THE EXTENSION PHASE OF THE PRIOR LURASIDONE STUDY. 3. TEH SUBJECT IS JUDGED BY THE INVESTIGATOR TO BE SUITABLE FOR PARTICIPATION IN A CLINICAL STUDY INVOLVING OPEN-LABEL LURASIDONE TREATMENT AND IS ABLE TO COMPLY WITH THE PROTOCOL. 4. THE SUBJECT, IN THE INVESTIGATOR´S JUDGMENT, MAY BENEFIT FROM CONTINUED TREATMENT WITH LURASIDONE. 5. FEMALE SUJECT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE ADEQUATE AND RELIABLE CONTRACEPTION THROUGHOUT THE STUDY AND FOR AT LEAST 30 DAYS AFTER THE LAST DSE OF LURASIDONE HAS BEEN TAKEN. IN THE INVESTIGATOR´S JUDGMENT, THE SUBJECT WILL ADHERE TO THIS REQUIREMENT.
Exclusion criteria
Exclusion criteria: 1. THE SUBJECT IS CONSIDERED, BY THE INVESTIGATOR, TO BE AT IMMINENT RISK FOR HOMICIDAL OR SUICIDAL BEHAVIOR. 2. THE SUBJECT REQUIRES TREATMENT WITH ANY POTENT CYTOCHROME P4503A4 (CYP3A4) INHIBITORS OR INDUCERS DURING THE STUDY (SEE APPENDIX A). 3. THE SUBJECTS RESIDES IN A COUNTRY WHERE LURASIDONE HAS BEEN APPROVED FOR ANY INDICATION. 4. THE SUBJECT IS PREGNANT OR NURSING (LACTATING) OR IS PLANNING PREGNANCY WHITIN THE PROTECTED DURATION OF THE STUDY. 5. THE SUBJECT ANSWERS YES TO SUICIDAL IDEATION ITEMS 4 OR 5 ON THE C-SSRS. 6. THE SUBJECT IS CURRENTLY ENROLLED IN ANY OTHER INVESTIGATIONAL STUDY
Countries
Canada, Colombia, Czech Republic, France, India, Lithuania, Romania, Slovakia, South Africa, Ukraine
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed