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    Summary
    EudraCT Number:2012-004132-33
    Sponsor's Protocol Code Number:D1050304
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-004132-33
    A.3Full title of the trial
    A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose,
    Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features (Protocol No D1050304)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Luradisone for the treatment of depression disorder
    A.4.1Sponsor's protocol code numberD1050304
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSunovion Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide clinical trials
    B.5.2Functional name of contact pointRosemary Brennecke
    B.5.3 Address:
    B.5.3.1Street Address1000 Continental Drive, suite 290
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA, 19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016109642016
    B.5.5Fax number0016102250050
    B.5.6E-mailrosemary.brennecke@wwctrials.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLurasidone
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 367514-88-3
    D.3.9.2Current sponsor codeSM-13496
    D.3.9.3Other descriptive nameLurasidone Hydrochloride
    D.3.9.4EV Substance CodeSUB34204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder (MDD)
    E.1.1.1Medical condition in easily understood language
    Major Depressive Disorder
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lurasidone (20, 40, and 60 mg/day, flexibly dosed) compared to placebo for the treatment of subjects with major depressive disorder (MDD) currently experiencing a major depressive episode (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR]) with mixed features as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
    E.2.2Secondary objectives of the trial
    Mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS) total score
     Mean change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score and SDS subscale scores
     Mean change from baseline to endpoint in the Hamilton Rating Scale for Anxiety (HAM-A) total score
     Safety end tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
     Subject is 18 to 75 years of age, inclusive.
     Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders – Clinical Trial version [SCID-CT]).
    Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Lurasidone Protocol D1050304):
    o Elevated, expansive mood
    o Inflated self-esteem or grandiosity
    o More talkative than usual or pressure to keep talking
    o Flight of ideas or subjective experience that thoughts are racing
    o Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
    o Increased or excessive involvement in activities that have a high potential for painful consequences (eg, engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
    o Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)
    Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline.
    E.4Principal exclusion criteria
    Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
     Subject answers “yes” to “Suicidal Ideation” Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
     Subject has attempted suicide within the past 3 months.
     Subject has a lifetime history of any bipolar I manic or mixed manic episode.
     Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change from baseline to the 6-week study endpoint in MADRS total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    The key secondary endpoint is the mean change from baseline to
    the 6-week study endpoint in CGI-S score

    Other secondary endpoints include the following:
     Mean change from baseline to endpoint in the YMRS total score
     Mean change from baseline to endpoint in the SDS total score and SDS subscale scores
     Mean change from baseline to endpoint in the HAM-A total score
     Proportion of subjects who achieve a response, defined as ≥ 50% reduction from baseline on the MADRS total score at endpoint
     Proportion of subjects who achieve a remission, defined as a MADRS total score of ≤ 12 at endpoint
     Proportion of subjects with treatment-emergent mania, assessed by a YMRS total score of ≥ 16 on any two consecutive visits or at the final assessment, or an AE of mania or
    hypomania

    The safety objectives of this study include evaluation of the following:
     Proportion of subjects with AEs and SAEs, and discontinuations due to AEs and SAEs
     Vital signs and ECG measurements
     Movement disorders assessed by the AIMS, BARS, and SARS
     Weight and laboratory measures
     Mean change from baseline to endpoint in sexual functioning based on CSFQ total score and CSFQ subscale scores
     Frequency and severity of suicidality using C-SSRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Serbia
    Ukraine
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standar care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-03
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