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Lurasidone Extended Use Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01485640
First received: December 1, 2011
Last updated: March 12, 2015
Last verified: March 2015
  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 (NCT00868959 and NCT01566162) 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:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.


Secondary Outcome Measures:
  • Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.


Enrollment: 162
Study Start Date: June 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485640

  Show 46 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01485640     History of Changes
Other Study ID Numbers: D1050298  2011-000682-12 
Study First Received: December 1, 2011
Results First Received: February 26, 2015
Last Updated: March 12, 2015
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:
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 29, 2016