A 24-WEEK, FLEXIBLE-DOSE, OPEN-LABEL EXTENSION STUDY OF LURASIDONE FOR THE TREATMENT OF BIPOLAR I DEPRESSIO

Not Applicable

• Registration Number: PER-034-11
• Lead Sponsor: SUNOVION PHARMACEUTICALS INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. SUBJECT PROVIDES WRITTEN INFORMED CONSENT AND IS WILLING AND ABLE TO COMPLY WITH THE PROTOCOL, IN THE OPINION OF THE INVESTIGATOR.
2. SUBJECT IS JUDGED BY THE INVESTIGATOR TO BE SUITABLE FOR PARTICIPATION IN A 24-WEEK CLINICAL INVOLVING OPEN-LABEL LURASIDONE TREATMENT.
3. SUBJECT HAS COMPLETED THE 6-WEEK TREATMENT PERIOD AND ALL REQUIRED ASSESSMENTS ON THE FINAL STUDY VISIT (DAY 42) OF STUDIES D1050235, D1050236 OR D1050292.
4. SUBJECTS IS NOT PREGNANT (MUST HAVE A NEGATIVE URINE PREGNANCY TEST AT DAY 42 IN STUDIES D1050235, D1050236 OR D1050292) OR NURSING (MUST NOT BE LACTATING) AND IS NOT PLANNING PREGNANCY WITHIN THE PROJECTED DURATION OF THE STUDY.
5. FEMALE SUBJECT WHO IS REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE ADEQUATE AND RELIABLE CONTRACEPTION THROUGHOUT THE STUDY AND FOR AT LEAST 30 DAYS AFTER THE LAST DOSE OF LURASIDONE HAS BEEN TAKEN. IN THE INVESTIGATOR´S JUDGMENT, THE SUBJECT WILL ADHERE TO THIS REQUIREMENT.
ADEQUATE CONTRACEPTION IS DEFINED AS CONTINUOUS USE OF TWO BARRIER METHODS (e.g., CONDOM AND ESPERMICIDE OR DIAPHRAGM WITH SPERMICIDE) OR HORMONAL CONTRACEPTIVE. ACCEPTABLE HORMONAL CONTRACEPTIVES INCLUDE THE FOLLOWING: CONTRACEPTIVE IMPLANT (SUCH AS NORPLANT®) IMPLANTED AT LEAST 90 DAYS PRIOR TO BASELINE; B) INJECTABLE CONTRACEPTION (SUCH AS MEDROXYPROGESTERONE ACETATE INJECTION) 

Exclusion Criteria

1. SUBJECT IS CONSIDERED BY THE INVESTIGATOR TO BE AT IMMINENT RISK OF SUICIDE, INJURY TO SELF OR OTHERS, OR DAMAGE TO PROPERTY.
2. SUBJECTS SCORES ≥ 4 ON MADRS ITEM NUMBER 10 (SUICIDAL THOUGHTS) AT BASELINE (DAY 42 IN STUDIES D1050235, D1050236 OR D1050292).
3. SUBJECT REQUIRES TREATMENT WITH ANY POTENT CYP3A4 INHIBITORS OR INDUCERS DURING THE STUDY (SEE APPENDIX 5). SUBJECT REQUIRES TREATMENT WITH A DRUG THAT CONSISTENTLY PROLONGS THE qtc INTERVAL (SEE APPENDIX 4)
4. SUBJECT CURRENTLY HAS A CLINICALLY SIGNIFICANT NEUROLOGICAL, METABOLIC (INCLUDING TYPE 1 DIABETES), HEPATIC, RENAL, HEMATOLOGICAL, PULMONARY, CARDIOVASCULAR, GASTROINTESTINAL, AND/OR UROLOGIC DISORDER SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE (UNCONTROLLED) OR CENTRAL NERVOUS SYSTEM SYSTEM (CNS) INFECTION THAT WOULD POSE A RISK TO THE SUBJECT IF THEY WERE TO PARTICIPATE IN THE STUDY OR THAT MIGTH CONFOUND THE RESULTS OF THE STUDY. SUBJECTS WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) SEROPOSITIVITY(OR HISTORY OF SEROPOSITIVITY) WILL BE EXCLUDED.
NOTE: ACTIVE MEDICAL CONDITIONS THAT ARE MINOR OR WELL-CONTROLLED ARE NOT EXCLUSIONARY IF THEY DO NOT AFFECT RISK TO THE SUBJECT OR THE STUDY RESULTS. IN CASES IN WHICH THE IMPACT OF THE CONDITION UPON RISK TO THE SUBJECT OR STUDY RESULTS IS UNCLEAR, THE MEDICAL MONITOR SHOULD BE CONSULTED.  

Study & Design

• Study Type: Interventional
• Study Design: Not specified