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    Summary
    EudraCT Number:2012-000309-60
    Sponsor's Protocol Code Number:120101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-08
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2012-000309-60
    A.3Full title of the trial
    Biochemical and neuropsychological effects on Premenstrual Dysphoric Disorder after acute administration of escitalopram
    Biokemiska och neuropsykologiska effekter av akut tillförsel av escitalopram vid premenstruellt dysforiskt syndrom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanisms behind the positive effect of the drug escitalopram on premenstrual dysphoric disorder
    Mekanismer bakom läkemedlet escitaloprams positiva effekt vid premenstruellt dysforiskt syndrom
    A.3.2Name or abbreviated title of the trial where available
    Biokemiska och neuropsykologiska effekter av akut tillförsel av escitalopram vid PMDS
    A.4.1Sponsor's protocol code number120101
    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 SponsorGöteborgs universitet
    B.1.3.4CountrySweden
    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 supportGöteborgs universitet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGöteborgs universitet
    B.5.2Functional name of contact pointSektionen för farmakologi
    B.5.3 Address:
    B.5.3.1Street AddressBox 431
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code405 30
    B.5.3.4CountrySweden
    B.5.4Telephone number+46317863430
    B.5.6E-mailelias.eriksson@neuro.gu.se
    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 Cipralex
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCipralex
    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 INNESCITALOPRAM
    D.3.9.4EV Substance CodeSUB16425MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 20
    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
    Premenstrual Dysphoric Disorder
    Premenstruellt dysforiskt syndrom.
    E.1.1.1Medical condition in easily understood language
    Premenstrual Dysphoric Disorder
    Premenstruellt dysforiskt syndrom.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10051537
    E.1.2Term Premenstrual dysphoric disorder
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    It is known that the serotonin reuptake inhibitor escitalopram is effective for the treatment of premenstrual dysphoric disorder. The aim of the present study is to investigate the mechanisms underlying this effect. The questions to be addressed are i) if women with PMDD display differences in blod and/or CSF between the symptomatic (premenstrual) and the asymptomatic (postmenstrual) cyclic phase regarding levels of gonadal steroids, neurosteroids, inflammatory markers or various markers of brain neurotransmission, ii) to which extent these parameters correlate with each other and/or symptom intensity and iii) to what extent these parameters are affected by treatment with escitalopram.
    Det är känt att serotoninåterupptagshämmaren escitalopram har gynnsam effekt vid premenstruellt dysforiskt syndrom. Syftet med den aktuella studien är att undersöka mekanismerna bakom denna effekt. Frågeställningarna är i) om det, hos kvinnor med PMDS, går att identifiera skillnader i blod och/eller ryggmärgsvätska mellan symptomatisk (premenstruell) och aymptomatisk (postmenstruell) cykelfas i blod och/eller ryggmärgsvätska vad avser nivåer av könshormoner, neurosteroider, inflammatoriska markörer eller markörer för central nervtransmission, ii) i vad mån dessa parametrar korrelerar med varandra och/eller med symtomintensiteten och iii) i vad mån dessa parametrar påverkas av behandling med escitalopram.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion cirteria for patients with Premenstrual Dysphoric Disorder:
    1. Age: 18-45 years
    2. Regular menstrual cycle.
    3. Diagnostic criteria A-C for PDD according to DSM-IV.
    4. At least 50% elevation of the symptom irritability from follicular phase (mean from day 6 to 10) to luteal phase (mean from day -5 to -1) measured with daily VAS scale (1-100 mm). During the last 5 days of the luteal phase the mean score for irritability must be ≥ 30 mm.
    5. Written informed consent.
    Inklusionskriterier för patienter med premenstruellt dysforiskt syndrom:
    1. Ålder:18-45 år.
    2. Regelbundna menstruationer.
    3. Uppfyller kriterierna A-C för premenstruellt dysforiskt syndrom enligt DSM-V
    4. Uppvisar minst 50% ökning av symptomet irritabilitet från follikelfas (medelvärde av dag 6-10) till lutealfas (medelvärde av dag -5 - -1) mätt med VAS-skala (1-100 mm)- Under lutealfasens 5 sista dagar skall medelvärdet för detta symptom dessutom vara ≥30 mm.
    5. Skriftligt informerat samtycke
    E.4Principal exclusion criteria
    Exclusion criteria:

    1. Current (<1 year) psychiatric disorder other than premenstrual dysphoric disorder according to M.I.N.I. diagnostic interview.
    2. Moderate or high suicide risk according to M.I.N.I. diagnostic interview.
    3. Current regular psychopharmacological treatment (including anxiolytics and sedative-hypnotics).
    4. Earlier experience of SSRI indicating that patient does not tolerate this treatment. Known intolerance to any excipient in the given tablets.
    5. Known QT prolongation or enhanced risk for QT prolongations.
    6. Current or past somatic disease and/or past psychiatric disorder and/or current medication regarded by the clinical investigator as potentially interfering with study examinations and/or the effect of escitalopram, or in other way inappropriate or representing a risk according to the clinical investigator.
    7. Breastfeeding or pregnancy/inadequate contraceptive method.
    8. Circumstances indicating to the clinical investigator that the participant not will be able to complete the trial.
    9. Difficulties in understanding the implications of participation in the study, e.g. language difficulties.
    Exklusionskriterier:

    1. Pågående (<1 år) psykiatrisk sjukdom annan än premenstruellt dysforiskt syndrom efter vad som framkommer av en M.I.N.I. diagnostisk intervju
    2. Måttlig eller hög suicidrisk enligt MINI-intervju.
    3. Pågående regelbunden medicinering med psykofarmaka (inkluderat anxiolytika och sömnmedel).
    4. Tidigare erfarenhet av ett SSRI-preparat som talar för att patienten inte fördrar denna typ av farmaka. Känd överkänslighet mot någon hjälpsubstans i den aktuella tabletten.
    5. Känd QT-förlängning eller ökad risk för QT-förlängning.
    6. Pågående eller tidigare kroppslig sjukdom och/eller tidigare psykiatrisk sjukdom och/eller pågående medicinering som av klinisk prövare anses kunna påverka utfallet av de planerade undersökningarna och/eller effekten av escitalopram, eller som av annat skäl enligt klinisk prövare gör medverkan i studien riskabel eller av annat skäl olämplig.
    7. Amning eller graviditet/otillfredsställande antikonceptionsmetod.
    8. Faktorer som ger klinisk prövare skäl att förmoda att deltagaren ej kommer att fullfölja studien.
    9. Svårigheter att förstå innebörden av att deltaga i studien, t.ex. beroende på språksvårigheter.
    E.5 End points
    E.5.1Primary end point(s)
    Serotonin levels in CSF
    Serotoninnivåer i cerebrospinalvätska
    E.5.1.1Timepoint(s) of evaluation of this end point
    After inclusion in the trial each patient is monitored during four complete menstruation cycles and the beginning of the fifth, i.e. approx. four months.
    Efter att ha inkluderats i studien följs varje patient under fyra hela menstruationscykler och under inledningen av den femte, dvs ca fyra månader.
    E.5.2Secondary end point(s)
    Not relevant.
    Ej relevant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not relevant.
    Ej relevant
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    This study aims to investigate the effect of escitalopram treatment on a number of biological and psychological parameters. The evaluation consists of comparisons of these parameters between the menstruation cycle with escitalopram treatment and i) corresponding levels in luteal phase before treatment, ii) corresponding levels in follicle phase before treatment, iii) corresponding levels during placebo treatment (i.e. luteal phase) and corresponding levels in the placebo group.
    Detta är en studie vars syfte är att undersöka effekten av escitalopram-behandling på en rad biologiska och psykologiska parametrar. Utvärderingen består i att vi jämför dessa parametrar under den cykel som patienten står på escitalopram i) med motsvarande nivåer före behandling i lutealfas, ii) med motsvarande nivåer före behandling i follikelfas, iii) med motsvarande nivåer under behandling med placebo (dvs i lutealfas) med motsv nivåer i den grupp som samtidigt behandlas med placebo.
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    Deltagaren kommer efter avslutad studie antingen att följas upp av samma läkare som i studien, eller remitteras
    till lämplig vårdenhet för uppföljning.
    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 Decision2016-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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