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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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
 Drug: Lurasidone
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

Resource links provided by NLM:

Drug Information available for: Lurasidone
U.S. FDA Resources

Further study details as provided by Sunovion:

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: 600
Study Start Date: June 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone
Lurasidone flexibly dosed
 Drug: Lurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485640

Contacts
Contact: Study Manager 1-888-394-7377

  Show 38 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01485640     History of Changes
Other Study ID Numbers: D1050298, 2011-000682-12
Study First Received: December 1, 2011
Last Updated: January 17, 2013
Health Authority: 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:
Schizophrenia
bipolar disorder
Lurasidone
Latuda

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013