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    Summary
    EudraCT Number:2009-011824-79
    Sponsor's Protocol Code Number:91686125
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-05-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-011824-79
    A.3Full title of the trial
    Effects of fluoxetine on the outgrowth of the serotonergic system
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    'Fluoxetine and the developing brain'
    A.3.2Name or abbreviated title of the trial where available
    ePOD-SSRI
    A.4.1Sponsor's protocol code number91686125
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNWO
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademical medical Center
    B.5.2Functional name of contact pointDr.L.Reneman
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205668312
    B.5.5Fax number0031205669119
    B.5.6E-mailL.Reneman@amc.uva.nl
    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 Fluoxetine CF 20, dispergeerbare tabletten 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm Services B.V
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameFluoxetine CF 20
    D.3.2Product code RVG 24609
    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 INNFLUOXETINE
    D.3.9.1CAS number 54910893
    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
    We investigate whether the effects fluoxetine (Prozac®) on the outgrowth of the serotonergic system are dependent on age. In a 16 week multicenter randomized, double-blind, placebo controlled trial with fluoxetine in 80 adolescents and adults suffering from MDD and/or anxiety, the effect of age is investigated using state of the art in vivo Magnetic Resonance Imaging (MRI) techniques that allow determination of the functional status of the 5-HT neurotransmitter system with pharmacological MRI.
    E.1.1.1Medical condition in easily understood language
    We investigate the effects of fluoxetine on the brain using MRI by treating 80 adolescents and adults diagnosed with major depression/anxiety with fluoxetine or placebo for 16 weeks.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10056941
    E.1.2Term MRI brain
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To report on the age-dependency of the effect(s) of the SSRI fluoxetine on the outgrowth of the serotonergic system using Magnetic Resonance Imaging (MRI) techniques
    E.2.2Secondary objectives of the trial
    - To report on the age-dependency of the effect of fluoxetine on the outgrowth of the serotonergic system using several behavioral outcome measures related to 5-HT (emotional processing, verbal memory and impulsivity) using fMRI and a neuropsychological test battery.
    - To report on the age-dependency of the effect of fluoxetine on the 5-HT driven hypothalamic-pituitary-adrenal (HPA) axis, using cortisol and prolactine measures (baseline and after 5-HT challenge)
    - To report on the age-dependency of the effect of fluoxetine on growth, pubertal development and insuline-like growth factor (IGF-1) levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    40 adolescent (10-14 years of age) and 40 adult (23-30 years of age) female outpatients diagnosed with moderate or severe MDD and/or anxiety disorder, as defined in the DSM-IV, and in need of pharmacotherapy according to existing guidelines.
    E.4Principal exclusion criteria
    - IQ < 70 (subtests Wechsler Intelligence Scale for Children-Revised (WISC-R); Wechsler, 1981 or National Adult Reading Test (NART); Nelson, 1991).
    - Other current Axis I psychiatric disorders like psychotic disorder, autistic disorder, ADHD and substance abuse, as defined in the DSM-IV.
    - Current or previous treatment with medications that influence the 5-HT system (for adults before 23 years of age): SSRIs, tricyclic antidepressants, triptans, MAO inhibitors. Current or previous (ab)use (for adults before 23 years of age): of MDMA, amphetamine, methamphetamine, cocaine, heroine and LSD).
    - Prenatal use of SSRI by mothers of the patients.
    - Current treatment with CBT in adults
    - Acute suicidality
    - Contraindications to fluoxetine treatment (known hypersensitivity to one of the contents, use of other SSRIs or pimozide (Orap), thioridazine or monoamine oxidase inhibitors (MAOI) and Saint John’s Wort).
    - Contraindications to MRI scanning (such as any kind of irremovable metal inside the body, claustrophobia, etc)
    - Pregnancy, breastfeeding or sexually active and not using/willing to use medically accepted means of contraception.
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters
    Difference in functioning of the 5-HT system after treatment, when compared to baseline conditions, as measured by:
    - phMRI: % change in citalopram induced BOLD signal from baseline
    - DTI: % change in FA values from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 0 (baseline) and week 19 (3weeks wash out period)
    E.5.2Secondary end point(s)
    - fMRI: % change in task related BOLD signal from baseline
    - 1H-MRS: ratio of the 1.28 ppm peak to creatine peak
    - Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer)tasks addressing (verbal) memory, impulse control and emotional processing, compared to baseline measurements.
    - 5-HT-related HPA axis functioning: changes in baseline cortisol levels and cortisol and prolactine response after 5-HT challenge
    - Growth: % change in length, body weight, Tanner stage and IGF-1 levels from baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week -2(2 weeks prior to baseline), week 0, week 18 and week 19
    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 No
    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 No
    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 trial4
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    The last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 40
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state80
    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)
    After the subject has ended the participation in the trial, the subject will receive normal treatment and care continued at AMC or local site.
    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 Decision2009-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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