Lurasidone Extended Use Study
This study is currently recruiting participants.
Verified November 2013 by Sunovion
Information provided by (Responsible Party):
First received: December 1, 2011
Last updated: November 4, 2013
Last verified: November 2013
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study and who may benefit from continued treatment with lurasidone.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
Primary Outcome Measures:
- Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Safety assessments will include spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring, clinical laboratory tests (hematology, clinical chemistry, and urinalysis), vital signs, weight, and concomitant medications.
Investigators will evaluate the long-term effectiveness of lurasidone by utilizing the Clinical Global Impression-Severity (CGI-S) scale.
Investigators will assess the potential for suicidal AEs (suicidal behavior and suicidal ideation) by utilizing the C-SSRS.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Lurasidone flexibly dosed
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
- The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
- The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
- The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
- The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
- The subject resides in a country where lurasidone has been approved for any indication.
- The subject is currently enrolled in any other investigational study.
- The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485640
|Contact: Study Manager
||Medical Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 1, 2011
||November 4, 2013
||United States: Food and Drug Administration
India: Drugs Controller General of India
Czech Republic: State Institute for Drug Control
Ukraine: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Colombia: National Institutes of Health
Peru: Ministry of Health
Canada: Health Canada
South Africa: Medicines Control Council
Slovakia: State Institute for Drug Control
Keywords provided by Sunovion:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features