Lurasidone Extended Use Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01485640 |
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Recruitment Status :
Completed
First Posted : December 5, 2011
Results First Posted : March 11, 2015
Last Update Posted : November 4, 2016
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Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Bipolar Disorder | Drug: Lurasidone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 162 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | February 2014 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Lurasidone
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lurasidone
Lurasidone flexibly dosed
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Drug: Lurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food |
Primary Outcome Measures :
- Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs [ Time Frame: 18 months ]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 ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485640
Locations
Show 46 study locations
Sponsors and Collaborators
Sunovion
Investigators
| Study Director: | Medical Director, MD | Sunovion |
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT01485640 |
| Other Study ID Numbers: |
D1050298 2011-000682-12 ( EudraCT Number ) |
| First Posted: | December 5, 2011 Key Record Dates |
| Results First Posted: | March 11, 2015 |
| Last Update Posted: | November 4, 2016 |
| Last Verified: | September 2016 |
Keywords provided by Sunovion:
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Schizophrenia bipolar disorder Lurasidone Latuda |
Additional relevant MeSH terms:
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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 |