A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Key facts

Study ID

NCT01566162

Run by

Sumitomo Pharma America, Inc.

People needed

191

Starts

2012-04-01

Expected to finish

2013-11-01

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has agreed to participate by providing written informed consent.
• Subject will be eligible to participate if one of the following criteria is met:
• Subject has completed the 28-week double-blind phase of study D1050238
• Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
• Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
• Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
• 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.

You may not qualify if…

• Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
• 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 the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
• Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.

Where it is running

• Woodland International Research Inc. — Little Rock, Arkansas, United States
• Comprehensive Clinical Development Inc. — Cerritos, California, United States
• Diligent Clinical Trials — Downey, California, United States
• Synergy Clinical Research Center — Escondido, California, United States
• CNS Network — Garden Grove, California, United States
• AXIS Clinical Trials — Los Angeles, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• CNRI-Los Angeles. LLC — Pico Rivera, California, United States
• California Neuropsychopharmacolgoy Clinical Research Insitute — San Diego, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• Collaborative Neuroscience Network — Torrance, California, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Accurate Clinical Trials — Kissimmee, Florida, United States
• Galiz Research — Miami Springs, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Comprehensive NeuroScience Inc. — Atlanta, Georgia, United States
• Lake Charles Clinical Trials, LLC — Lake Charles, Louisiana, United States
• Lousiana Clinical Research, LLC — Shreveport, Louisiana, United States
• Center for Behavioral Health, LLC — Rockville, Maryland, United States
• Psychiatric Care and Research Center — O'Fallon, Missouri, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• Robert Lynn Horne, MD — Las Vegas, Nevada, United States
• K and S Professional Research Services — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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