A 12-Week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia

Phase 1

• Conditions: Schizophrenia; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-000061-23-PL
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-24
• Study Completion: 2019-01-31
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

1. Subject must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor per local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
2. Subject has completed the 6-week double-blind phase of study D1001066 and has completed all required assessments on the final study visit.
3. Subject is judged to be suitable for participation in a 12-week clinical study involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
4. Female subjects must not be pregnant (must have a negative urine pregnancy test at Visit 1E [Study Visit Number 9 in Study D1001066]) nor nursing (must not be lactating) and not planning to become pregnant within the projected duration of the study.
5. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken.
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 273
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, or subject answers yes” to Suicidal Ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Visit 1E (Study Visit Number 9 in Study D1001066). Subjects who answer yes” to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
2. Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator.
3. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study.
4. Subject is otherwise considered ineligible for the study by the Investigator.

Study & Design

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