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Lurasidone Extended Use Study

This study is currently recruiting participants.
Verified January 2013 by Sunovion
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01485640
First received: December 1, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes

December 1, 2011
January 17, 2013
June 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01485640 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lurasidone Extended Use Study
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Bipolar Disorder
Drug: Lurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Experimental: Lurasidone
Lurasidone flexibly dosed
Intervention: Drug: Lurasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Both
Not Provided
No
Contact: Study Manager 1-888-394-7377
Canada,   Colombia,   Czech Republic,   France,   India,   Lithuania,   Romania,   Slovakia,   South Africa,   Ukraine
 
NCT01485640
D1050298, 2011-000682-12
No
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP