Pediatric Open-Label Extension Study
Condition: Schizophrenia; Autism; Bipolar Depression
MeSH terms: Schizophrenia; Bipolar Disorder
Intervention: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Intervention description: Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 702.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Autism; Lurasidone; Latuda

Summary:

      This is an open-label, 104-week, multicenter, extension study designed to evaluate the
      long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or
      80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the
      preceding studies, D1050301, D1050325, and D1050326
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent from parent(s) or legal guardian(s) with sufficient
             intellectual capacity to understand the study and support subjects' participation in
             the study procedures must be obtained for subjects who are not emancipated. In
             accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
             requirements, the subject will complete an informed assent when developmentally
             appropriate, to participate in the study before conduct of any study-specific
             procedures.

          -  Subject has completed Study D1050301 (Visit 9) OR

          -  Subject has completed Study D1050325 (Visit 9) OR

          -  Subject has completed Study D1050326 (Visit 8)

          -  Subject is judged by the investigator to be appropriate for participation in a
             104-week clinical trial in an outpatient setting involving open-label lurasidone
             treatment, and is able to comply with the protocol.

          -  A reliable informant (eg, parent, legal guardian, or caregiver) must be available to
             accompany the subject at each visit. For subjects entering from Study D1050325, the
             reliable caregiver must also oversee the administration of the study drug throughout
             the study

          -  Females who participate in this study:

               -  are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-

               -  practices true abstinence (consistent with lifestyle) and must agree to remain
                  abstinent from signing informed consent to at least 7 days after the last dose of
                  study drug has been taken; -OR-

               -  are sexually active and willing to use a medically effective method of birth
                  control (eg, male using condom and female using condom, diaphragm, contraceptive
                  sponge, spermicide, contraceptive pill, or intrauterine device) from signing
                  informed consent to at least 7 days after the last dose of study drug has been
                  taken.

          -  Males must be willing to remain sexually abstinent (consistent with lifestyle) or use
             an effective method of birth control (eg, male using condom and female using condom,
             diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine
             device) from signing informed consent to at least 7 days after the last dose of study
             drug has been taken.

        Exclusion Criteria:

          -  Subject is considered by the investigator to be at imminent risk of suicide.

          -  Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive
             dyskinesia, or any other moderate or severe movement disorder. Severity to be
             determined by the investigator.