A 12-week, multicenter, open-label extension study in subjects with schizophrenia.

Conditions: Schizophrenia.
MedDRA version: 15.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2011-004790-90-IT

Lead Sponsor: SUNOVION PHARMACEUTICALS INC.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1. Subjects provides written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator. 2. Subject has completed the 28-week double-blind phase of study D1050238 or Subject has experienced a protocol-defined relapse event during the double-blind phase in study D1050238 and has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238. or Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor and has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238. 3. Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. 4. Subject is not pregnant at the extension baseline visit (must have a negative urine pregnancy test at the final study visit in Study D1050238)or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study. 5. Males and female subjects who are of reproductive potential agree 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. 6. Subject is in good physical health on the basis of physical examination at the extension baseline visit (performed at the final study visit in Study D1050238).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
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, injury to self or to others, or damage to property.
2. 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 Columbia Suicide
Severity Rating Scale (C-SSRS) at the extension baseline visit (final
study visit in Study D1050238). Subjects who answer yes to this
question must be referred to the Investigator for follow-up evaluation.
3. Subject requires treatment with any potent CYP3A4 inhibitors or
inducers during the study. Subject requires treatment with a drug that
consistently prolongs the QTc interval.
4. Subject currently has a clinically significant neurological, metabolic
(including type 1 diabetes), hepatic, renal, hematological, pulmonary,
cardiovascular, gastrointestinal, and/or urological disorder such as
unstable angina, congestive heart failure (uncontrolled), or central
nervous system (CNS) infection that would pose a risk to the subject if
they were to participate in the study or that might confound the results
of the study. Subjects with human immunodeficiency virus (HIV)
seropositivity (or history of seropositivity) will be excluded.
Note: Active
medical conditions that are minor or well-controlled are not exclusionary
if they do not affect risk to the subject or the study results.
5. Subject exhibits evidence of severe tardive dyskinesia, severe
dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator.
6. Subject has presence of abnormal electrocardiogram (ECG) at the
extension baseline visit (final study visit in Study D1050238).