A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS

Phase 1

• Conditions: Extension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I Depression; MedDRA version: 19.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.0Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-001694-24-HU
• Lead Sponsor: SUNOVION PHARMACEUTICALS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-10
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 574

Inclusion Criteria

1. 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. 2. Subject has completed Study D1050301 or 325 (Visit 9); OR Subject has completed Study D1050326 (Visit 8). 3. 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. 4. 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. 5. 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. 6. 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 574
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject is considered by the investigator to be at imminent risk of suicide.
2. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified