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    Summary
    EudraCT Number:2014-004162-17
    Sponsor's Protocol Code Number:A0501061
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-24
    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 number2014-004162-17
    A.3Full title of the trial
    A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
    A.4.1Sponsor's protocol code numberA0501061
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00150306
    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 SponsorPfizer 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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number8007181021
    B.5.5Fax number3037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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.2.1.1.1Trade name Zoloft
    D.2.1.1.2Name of the Marketing Authorisation holderVarious including Pfizer Inc
    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 nameZoloft
    D.3.2Product code CP-51,974
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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
    Post-Traumatic Stress Disorder
    E.1.1.1Medical condition in easily understood language
    Disorder caused due to exposure to a traumatic event involving serious harm to self or others which produces intense fear, horror or a sense of helplessness.
    E.1.1.2Therapeutic area Not possible to specify
    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 evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with the diagnosis of Posttraumatic Stress Disorder.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
    2.Subjects must be male or non-pregnant, non-lactating female outpatients.
    3.Females of childbearing potential must have a negative serum pregnancy test prior to entry into the study.
    4.Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
    5.Subjects must be at least moderately ill, as indicated by a score of at least 30 on the University of California, Los Angeles (UCLA) PTSD-I and a Clinical Global Impression - Severity of Illness (CGI-S) score of higher than 4 at Screening Day 1, Screening Day 7, and Baseline (Screening Day 14).
    6.Subjects must be free of psychotropic medication for at least 2 weeks prior to the Baseline Visit (Screening Day 14) with the exception of fluoxetine. Subjects must be free of fluoxetine for at least 4 weeks prior to the Baseline Visit. Subjects were not to receive treatment with monoamine oxidase inhibitors (MAOIs) for at least 2 weeks after completion of this study.
    7.Subjects and their parent or legal guardian (in the case of abuse, the nonabusive parent or legal guardian) must be judged reliable for medication compliance. They must agree to keep appointments for study visits and for all tests and examinations required by the protocol.
    8.Prior to the subject’s participation in this study, informed assent or written informed consent must be obtained from the subject and written informed consent must be obtained from at least one parent or one legal guardian.
    E.4Principal exclusion criteria
    1.Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
    2.Subjects who are likely to or are at high risk for experiencing reexposure to their index trauma.
    3.Subjects who currently meet DSM-IV diagnosis or have a history of Bipolar Affective Disorder, Mania, Schizophrenia, Schizoaffective Disorder, Psychotic Disorder, Not Otherwise Specified (NOS), Autistic Spectrum Disorder, or Psychotic Disorder due to a general medical condition or substance use.
    4.Subjects who currently meet Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria for Obsessive Compulsive Disorder, Conduct Disorder, Dissociative Identity Disorder, or Delusional Disorder (defined by KSADS-PL).
    5.Subjects with a current primary diagnosis of Major Depressive Disorder, Panic Disorder, or Generalized Anxiety Disorder.
    6.Subjects with DSM-IV defined Attention Deficit/Hyperactivity Disorder whose management includes pharmacological management with agents other than central nervous system stimulants.
    7.Subjects with a history of, or who at screening currently meet DSM-IV criteria for bulimia or anorexia nervosa.
    8.Subjects with a history of suicide attempt or who would pose a significant suicidal or homicidal risk during the course of the study.
    9.Subjects who have met DSM-IV criteria for Substance Abuse or Dependence within the past 6 months.
    10.Subjects who have been responding to cognitive behavioral therapy or other psychotherapy as a treatment for PTSD within 2 months of the baseline visit. Subjects who are receiving supportive psychotherapy and/or family therapy, not specifically addressing symptoms of PTSD, may participate in the study as long as the therapy was begun at least 2 months prior to the baseline visit and is not discontinued during the course of the study.
    11.Subjects with a history of seizure disorder or who have cognitive or neurological deficits that would significantly limit their ability to perform the rating scales.
    12.Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG or laboratory tests.
    13.Subjects with any liver function test greater than twice the upper limit of the normal (ULN) range. If any liver function test is between 1.5 and twice the upper limit of the normal range, the subject’s eligibility must be discussed with the Pfizer Clinician.
    14.Subjects with a thyroid stimulating hormone (TSH) level significantly outside the range of normal, or who have a positive urine drug screen.
    15.Subjects who have taken any investigational drug within two weeks prior to Screening Visit 1.
    16.Subjects who require concomitant psychotropic medication, other than diphenhydramine or chloral hydrate for sleep.
    17.Subjects with a previous history of intolerance or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or sertraline, or who have previously failed to respond to a clinically adequate dose of SSRIs as defined by the American Academy of Child and Adolescent Psychiatry (Cohen, 1998).
    18.Subjects with any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I).Total Symptom Score for Diagnostic and Statistical Manual of Mental Disorders -IV (DSM-IV) at Week 10
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, End of Week 10
    E.5.2Secondary end point(s)
    1. Change From Baseline in UCLA PTSD-I. Total Symptom Score for DSM-IV at Week 1, 3, 5 and 7
    2. Child Stress Disorder Checklist (CSDC)
    3. Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R)
    4. Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
    5. Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale score at Week 1, 3, 5, 7, 10
    6. Clinical Global Impression - Improvement (CGI-I) Score
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline, Week 1, 3, 5, 7
    2. Baseline, End of Week 10
    3. Baseline, End of Week 10
    4. Baseline, End of Week 10
    5.Baseline, Week 1, 3, 5, 7, 10
    6. Week 1, 3, 5, 7, 10
    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 Yes
    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 No
    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? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    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
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 129
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 74
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 55
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 6 to 11 years and adolescents aged 12 to 17 years
    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 129
    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)
    None
    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: United States
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