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    Summary
    EudraCT Number:2018-001212-30
    Sponsor's Protocol Code Number:ECEP-BPD
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-001212-30
    A.3Full title of the trial
    A trial to study effects of a single dose Citalopram on emotion processing in female patients with Borderline Personality Disorder and the associated modulation of fMRI BOLD signals
    A.4.1Sponsor's protocol code numberECEP-BPD
    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 SponsorCentral Institute of Mental Health, represented by commercial and administrative Director
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim Pharma GmbH & Co KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentral Institute of Mental Health
    B.5.2Functional name of contact pointDept. of Psychosomatic Medicine and
    B.5.3 Address:
    B.5.3.1Street AddressJ5
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68159
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962117034002
    B.5.5Fax number+4962117034005
    B.5.6E-mailChristian.schmahl@zi-mannheim.de
    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 Citalopram
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Film-coated 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 INNCITALOPRAM HYDROBROMIDE
    D.3.9.3Other descriptive nameCITALOPRAM HYDROBROMIDE
    D.3.9.4EV Substance CodeSUB01320MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule
    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
    Borderline Personality Disorder
    E.1.1.1Medical condition in easily understood language
    Borderline Personality Disorder
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006034
    E.1.2Term Borderline personality disorder
    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 assess the effects of a single dose of Citalopram (20 mg) compared to placebo on BOLD responses on the amygdala and related brain structures induced by emotional stimuli using functional Magnetic Resonance Imaging (fMRI) in un-medicated female participants with Borderline Personality Disorder.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Healthy, female, aged 18-45 years
    ● Diagnosis of Borderline Personality Disorder according to DSM-IV
    ● Use of adequate contraception
    ● Fluent German speaker and capable of completing the fMRI and behavioural tasks
    ● Signed written informed consent prior to the first study related procedure
    E.4Principal exclusion criteria
    ● A history of alcohol or substance dependence within last 12 months prior to Visit 1
    ● A positive urine drug screen at Visit 1 (one re-test permitted within 1-3 days)
    ● A positive alcohol breath test at Visit 1
    ● A positive pregnancy test at visit 1
    ● Currently pregnant or trying to get pregnant or currently breast feeding
    ● Consumption of large amounts of caffeinated drinks (> 8 cups of standard caffeinated drinks or > 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day)
    ● Blood pressure outside normotensive range (systolic: 90 - 150 mm Hg, diastolic: 60 - 90 mm Hg ) at Visit 1
    ● Heart rate ≤ 50 beats per minute at Screening
    ● Abnormal ECG, including QTcF > 470 ms (women) based on the Fridericia correction where QTcF = QT/RR0.33
    ● Left-handed
    ● Smoking ≥ 20 cigarettes per day
    ● BMI (weight [kg]/height [m]²) outside range of 18 to 35 kg/m²
    ● Relevant history, or presence upon clinical examination of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures
    ● History of cancer, except for basal cell or Stage 1 squamous cell carcinoma of skin which is in remission for at least 5 years prior to study Visit 1
    ● Meeting the diagnostic criteria for a psychotic disorder or schizophrenia, as determined by the SCID-I at Visit 1
    ● Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack)
    ● A history of positive HIV test
    ● Medical history of cranial surgery
    ● Significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which might interfere with the performance of the behavioural tasks or fMRI tasks
    ● Treatment with psychotropic medication within 28 days prior to Visit 1 (except medication received will not interfere with the study procedures or compromise safety in opinion of investigator)
    ● Treatment with experimental drug and / or experimental medical device within 30 days of randomisation or within a period less than 5 times the drug’s half-life, whichever is longer
    ● Known hypersensitivity to Citalopram or any of their excipients.
    ● History of severe drug allergy or hypersensitivity
    ● Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
    ● History of claustrophobia or inability to tolerate scanner environment
    ● Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
    ● Clinically relevant structural brain abnormality as determined by prior MRI scan
    ● Planned medical treatment within the study period that might interfere with the study procedures.
    ● Staff member or relative of a staff member, is in a subordinate relationship with the Investigator
    ● Held in an institution by legal or official order
    ● Participation in other clinical trials or observation period of competing trials, respectively.
    ● Previous participation in this trial
    E.5 End points
    E.5.1Primary end point(s)
    Altered BOLD response amplitude in the OASIS paradigm in the following brain regions:
    ● Amygdala left
    ● Amygdala right
    ● Dorsolateral Prefrontal cortex left
    ● Dorsolateral Prefrontal cortex right
    ● Insula left
    ● Insula right
    ● Anterior cingulate cortex left
    ● Anterior cingulate cortex right
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Treatment visits day 7 and day 14
    E.5.2Secondary end point(s)
    Altered BOLD response amplitude (BOLD fMRI), functional connectivity, or blood flow (ASL-MRI) in other paradigms and/or other brain regions
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Treatment visits day 7 and day 14
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 30
    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 No
    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 state30
    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)
    Since a single dose of citalopram can be discontinued without Special measures there will be no Treatment or care after the subject has ended the participation in the Trial.
    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 Decision2018-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-22
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