Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Lurasidone

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    36 result(s) found for: Lurasidone. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-001523-39 Sponsor Protocol Number: D1050300 Start Date*: 2013-11-08
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A PHASE 1 OPEN-LABEL, MULTICENTER, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF LURASIDONE IN SUBJECTS 6 TO 17 YEARS OLD WITH SCHIZOPHRENIA SPE...
    Medical condition: schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10001064 Acute schizophrenia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003816-20 Sponsor Protocol Number: MARYLU Start Date*: 2021-11-09
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: IMPACT OF STRUCTURAL AND MYELIN ABNORMALITIES ON COGNITIVE IMPAIRMENTS IN RECENT-ONSET SCHIZOPHRENIA – before and after lurasidone treatment
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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: 2011-000682-12 Sponsor Protocol Number: D1050298 Start Date*: 2011-11-08
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
    Medical condition: Bipolar depression & schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    15.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    15.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) LT (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004789-14 Sponsor Protocol Number: D1050308 Start Date*: 2012-07-04
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder
    Medical condition: bipolar disorder I
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) BG (Completed) PL (Completed) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007483-42 Sponsor Protocol Number: D1050256 Start Date*: 2009-10-21
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depression
    Medical condition: Bipolar I depression
    Disease: Version SOC Term Classification Code Term Level
    13.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed) SK (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001694-24 Sponsor Protocol Number: D1050302 Start Date*: 2014-03-11
    Sponsor Name:SUNOVION PHARMACEUTICALS INC.
    Full Title: A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRIT...
    Medical condition: SCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) IT (Prematurely Ended) BG (Completed) Outside EU/EEA HU (Completed) GB (Completed) DE (Completed) PL (Completed) BE (Completed) FR (Ongoing)
    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: 2010-019778-34 Sponsor Protocol Number: D1050292 Start Date*: 2011-03-14
    Sponsor Name:Sunovion, Inc.
    Full Title: A RANDOMIZED, 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLEXIBLE-DOSE, PARALLEL-GROUP STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM OR DIVALPROEX FOR THE TREATMENT OF BIPOLAR I DEPRESSION IN SUBJECTS ...
    Medical condition: Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    12.1 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) LT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-007457-13 Sponsor Protocol Number: D1050236 Start Date*: 2009-10-21
    Sponsor Name:Sunovion Pharmaceuticals, Inc.
    Full Title: A Randomized, 6-Week, Double-Blind, Placebo-controlled, Fixed-Flexible-Dose, Parallel-Group Study of Lurasidone in the Treatment of Bipolar I Depression
    Medical condition: Bipolar depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-007482-23 Sponsor Protocol Number: D1050235 Start Date*: 2009-10-21
    Sponsor Name:Sunovion Pharmaceuticals, Inc.
    Full Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
    Medical condition: Bipolar depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004790-90 Sponsor Protocol Number: D1050307 Start Date*: 2012-09-26
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A 12-WEEK, MULTICENTER, OPEN-LABEL EXTENSION STUDY IN 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: 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: 2016-000061-23 Sponsor Protocol Number: D1001067 Start Date*: 2017-03-15
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A 12-Week, Open-Label Extension Study of Lurasidone (SM-13496) in 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: 2011-000986-10 Sponsor Protocol Number: D1050296 Start Date*: 2011-12-14
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FLEXIBLE-DOSE, PARALLEL-GROUP STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM OR DIVALPROEX FOR THE PREVENTION OF RECURRENCE IN SUBJECTS WITH BIPOLAR I DISO...
    Medical condition: Bipolar disorder I depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed) PL (Completed)
    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)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 19 19:06:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA