Bipolar depression & schizophrenia MedDRA version: 15.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.1 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
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 14 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 Investigator’s judgment, may benefit from continued treatment with lurasidone. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 372 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior. •The subject resides in a country where lurasidone has been approved for any indication. •The subject is currently enrolled in any other investigational study. •The subject answers “yes” to “Suicidal Ideation” Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety, tolerability and effectiveness of lurasidone in eligible subjects who have completed a prior lurasidone extension study;Secondary Objective: ;Primary end point(s): To evaluate the long-term safety, tolerability and effectiveness of lurasidone in eligible subjects who have completed a prior lurasidone extension study;Timepoint(s) of evaluation of this end point: Up to 18 months | — |
Countries
Canada, China, Colombia, Czech Republic, France, Germany, India, Japan, Lithuania, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Ukraine
Contacts
Public ContactJosephine Cucchiaro, PhD
Sunovion Pharmaceuticals Inc.
Outcome results
None listed