Health Condition 1: null- Bipolar disorder Health Condition 2: F319- Bipolar disorder, unspecified
Conditions
Interventions
Intervention1: Lurasidone flexibly dosed: doses of 20, 40, 60 or 80 mg/day will be taken orally with food.
Duration: 18 months
Intervention2: There is no comparator its a Long-Term, Multicenter, Open-
Sponsors
Sunovion Pharmaceuticals Inc
Quintiles Research I Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required. • 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 lurasidone 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. • The 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. • The subject, in the Investigatorâ??s judgment, may benefit from continued treatment with lurasidone. • Female subject 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 dose of lurasidone has been taken. In the Investigatorâ??s judgment, the subject will adhere to this requirement. Adequate contraception is defined as continuous use of two barrier methods (eg, condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive. Acceptable hormonal contraceptives include the following: (1) contraceptive implant (such as Norplant) implanted at least 90 days prior to baseline, (2) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to baseline, or (3) oral contraceptives taken as directed for at least 30 days prior to baseline. Subjects who are of non-reproductive potential, i.e, subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception. • The subject is in good physical health based on assessment by the Investigator. •Rollover subjects should be from India only
Exclusion criteria
Exclusion criteria: • The subject is considered, by the Investigator, to be at imminent risk for homicidal or suicidal behavior • The subject requires treatment with any potent cytochrome P4503A4 (CYP3A4) inhibitors or inducers during the study • The subject resides in a country where lurasidone has been approved for any indication. • The subject is pregnant or nursing (lactating) or is planning pregnancy within the projected duration of the study. • The subject answers â??yesâ?? to â??Suicidal Ideationâ?? Items 4 or 5 on the C-SSRS. • The subject is currently enrolled in any other investigational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments will include spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring, clinical laboratory tests (hematology, clinical chemistry, and urinalysis), vital signs, weight, and concomitant medications. Investigators will evaluate the long-term effectiveness of lurasidone by utilizing the Clinical Global Impression-Severity (CGI-S) scale. Investigators will assess the potential for suicidal AEs (suicidal behavior and suicidal ideation) by utilizing the C-SSRS. Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| This study is not designed to measure efficacy. However, the change from baseline in the CGI-S scores will be used to evaluate the long-term effectiveness of lurasidone treatment.Timepoint: 18 months | — |
Countries
Canada, Colombia, Czech Republic, France, India, Lithuania, Romania, Russian Federation, Slovakia, South Africa, Ukraine
Contacts
Public ContactSuchela Srivatsa
Quinitles Research (India) Private Limited
Outcome results
None listed