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    Summary
    EudraCT Number:2015-004905-17
    Sponsor's Protocol Code Number:PIR112487
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-08-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004905-17
    A.3Full title of the trial
    A randomised, double-blind, placebo controlled, parallel group , flexible dose study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder
    A.4.1Sponsor's protocol code numberPIR112487
    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 SponsorGlaxoSmithKline Research & Development
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd.
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11-1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4408007839733
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Paxil
    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 nameParoxetine
    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 INNPAROXETINE
    D.3.9.1CAS number 61869-08-7
    D.3.9.3Other descriptive namePAROXETINE
    D.3.9.4EV Substance CodeSUB09631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of paroxetine 10 to 40 mg/day (initial dose: 10 mg/day) orally administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD based on changes from baseline in the CDRS-R total score in a randomized, double-blind, placebo controlled, parallel group study
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Run-in period:
    A subject will be considered eligible for the study only if all of the following criteria apply at start of placebo run-in period.
    - Patients who are diagnosed with the following depressive disorders according to the DSM-IV-TR criteria, and currently presents with a depressive episodes. Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3)
    - 7 years and older and under 18 years old (at the time of consent obtained)
    - Patients with a total raw summary score on the CDRS-R of 45 or greater at the Week -2 visit.
    - Patients whose legally acceptable representative (e.g., caretaker, custodian) is able to give written consent to participation to this study. Patients aged 12 and above at the time of consent obtained should be able to sign the informed consent on one's own. Efforts should be exerted in obtaining the informed assent in writing from patients aged less than 12.
    - Patients with ideal body weight +/- 2SD
    - Gender: Male or female

    Treatment period:
    Subjects who meet the following criteria at Week 0 (Baseline) may be progressed to the Treatment period:
    - Patients with a total raw summary score on the CDRS-R at Week 0 visit of 45 or greater.
    E.4Principal exclusion criteria
    Run-in period:
    A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
    - Patients who in the investigator’s judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc)
    - Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases.
    - Patients with a history of a bipolar disorder, or complication of these diseases.
    - Patients with Attention-Deficit, or Hyperactivity Disorder
    - Patients with Mental Retardation or Pervasive Development Disorder
    - Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the Screening visit
    - Patients with past treatment experience with the investigational drug (i.e. paroxetine)
    - Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
    - Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
    - Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
    - Patients with past history of suicide attempt, self harm(excluding “no suicidal intent ” ), or an intentional overdose (excluding obviously unintentional overdose)
    - Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
    - Patients who have taken antidepressant medication 1 week prior to screening.
    - Patients with complicated disease of glaucoma.
    - Patients with convulsive disorders such as epilepsy or past history of these diseases.
    - Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of haemorrhage, or patients with bleeding tendency or haemorrhagic diathesis.
    - Patients with severe renal and hepatic disorder.
    - Patients with serious organic disorder in the brain.
    - Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
    - Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
    - Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
    - Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
    - Patients with clinical significant comorbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)

    Treatment period:
    Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
    - Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
    - Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or greater compared to that of Week -2.
    - Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
    - Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the CDRS-R total score at Week 8 [Time Frame: Baseline and Week 8]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: 8weeks
    E.5.2Secondary end point(s)
    •Plasma paroxetine concentrations for pharmacokinetics (PK) [Time Frame: Week 8 or Withdrawal (up to Week 8)]
    Time Frame: 8weeks

    •Change from Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) score [Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks

    •Change from baseline in the CDRS-R total score [Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks

    •Proportion of Clinical Global Impression-Global Improvement (CGI-GI) responders [Time Frame: Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Plasma paroxetine concentrations for pharmacokinetics (PK) [Time Frame: Week 8 or Withdrawal (up to Week 8)]
    Time Frame: 8weeks

    •Change from Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) score [Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks

    •Change from baseline in the CDRS-R total score [Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks

    •Proportion of Clinical Global Impression-Global Improvement (CGI-GI) responders [Time Frame: Weeks 1, 2, 3, 4, 6 and 8]
    Time Frame: 8weeks
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    This study was prematurely terminated due to inability to obtain sufficient enrolment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 244
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 319
    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)
    Study was prematurely terminated due to inability to obtain sufficient enrolment.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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