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Clinical trials for Lurasidone 80 mg AND Placebo

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: Lurasidone 80 mg AND Placebo. Displaying page 1 of 1.
    EudraCT Number: 2012-005271-14 Sponsor Protocol Number: D1050303 Start Date*: 2013-05-06
    Sponsor Name:Sunovion Pharmaceuticals Inc
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LOW-DOSE LURASIDONE IN ACUTELY PSYCHOTIC SUBJECTS WITH SCHIZOPHRENIA
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004873 10001064 Acute schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-001695-38 Sponsor Protocol Number: D1050301 Start Date*: 2014-03-11
    Sponsor Name:SUNOVION PHARMACEUTICALS INC.
    Full Title: A 6-WEEK RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LURASIDONE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10001064 Acute schizophrenia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) IT (Not Authorised) Outside EU/EEA BG (Completed) HU (Completed) GB (Completed) BE (Completed) FR (Ongoing) RO (Completed)
    Trial results: View results
    EudraCT Number: 2008-003984-38 Sponsor Protocol Number: D1050233 Start Date*: 2009-06-02
    Sponsor Name:Dainippon Sumitomo Pharma America Ltd
    Full Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND ACTIVE COMPARATOR CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF TWO DOSES OF LURASIDONE IN ACUTELY PSYCHOTIC SUBJECTS WITH SCHIZOPHR...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-004903-37 Sponsor Protocol Number: D1050326 Start Date*: 2014-07-30
    Sponsor Name:SUNOVION PHARMACEUTICALS INC.
    Full Title: A RANDOMIZED, 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLEXIBLE DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LURASIDONE IN CHILDREN AND ADOLESCENT SUBJECTS WITH BIPOLAR I DEPR...
    Medical condition: Bipolar I depression
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004873 10004936 Bipolar depression LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Not Authorised) BG (Completed) Outside EU/EEA HU (Completed) DE (Ongoing) GB (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-003820-40 Sponsor Protocol Number: D1050231 Start Date*: 2008-03-17
    Sponsor Name:Dainippon Sumitomo Pharma America, Inc.
    Full Title: A Phase 3 Randomized, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000060-42 Sponsor Protocol Number: D1001066 Start Date*: 2017-03-15
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lurasidone (SM-13496) in Acutely Psychotic Subjects with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001711-31 Sponsor Protocol Number: D1050238 Start Date*: 2012-02-29
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002213-19 Sponsor Protocol Number: ELICE-BD-O1 Start Date*: 2019-09-19
    Sponsor Name:University of British Columbia
    Full Title: A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Pa...
    Medical condition: Euthymic Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-003819-31 Sponsor Protocol Number: D1050229 Start Date*: 2008-04-02
    Sponsor Name:Dainippon Sumitomo Pharma America, Inc
    Full Title: A Phase 3 Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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