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    Summary
    EudraCT Number:2012-004062-17
    Sponsor's Protocol Code Number:WS1702721
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-004062-17
    A.3Full title of the trial
    Efficacy of add-on pregabalin in the treatment of Generalized Anxiety Disorder comorbid with Major Depressive Disorder: a double-blind placebo-controlled study.
    Τυχαιοποιημένη, διπλά-τυφλή μελέτη, ευέλικτης δόσης πρεγκαμπαλίνης έναντι εικονικού φαρμάκου, ως συμπληρωματική θεραπεία σε open-label εσιταλοπράμη, για την αντιμετώπιση της Γενικευμένης Αγχώδους Διαταραχής Συνυπάρχουσα με Μείζων Καταθλιπτική Διαταραχή.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Generalized Anxiety Disorder comorbid with Major Depressive Disorder.
    Αντιμετώπιση της Γενικευμένης Αγχώδους Διαταραχής Συνυπάρχουσα με Μείζων Καταθλιπτική Διαταραχή.
    A.4.1Sponsor's protocol code numberWS1702721
    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 SponsorAristotle University of Thessaloniki
    B.1.3.4CountryGreece
    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 supportAristotle University of Thessaloniki
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAristotle University of Thessaloniki
    B.5.2Functional name of contact pointKonstantinos Fountoulakis
    B.5.3 Address:
    B.5.3.1Street Address1, Stilponos Kiriakidi Street
    B.5.3.2Town/ cityThessaloniki
    B.5.3.3Post code54636
    B.5.3.4CountryGreece
    B.5.4Telephone number302310994622
    B.5.5Fax number302310266570
    B.5.6E-mailkfount@med.auth.gr
    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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 namePregabalin
    D.3.4Pharmaceutical form Capsule, hard
    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 INN7643
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codeD0400925
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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, hard
    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
    Generalized Anxiety Disorder comorbid with major depressive disorder.
    Γενικευμένη Αγχώδης Διαταραχής Συνυπάρχουσα με Μείζων Καταθλιπτική Διαταραχή.
    E.1.1.1Medical condition in easily understood language
    Psychiatric disorders.
    Ψυχιατρικές Διαταραχές.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    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 test whether pregabalin versus placebo as adjunctive treatment on open-label escitalopram will result in a greater reduction of anxiety symptoms, and simultaneously in better mental speed.
    Να ελεγχθεί εάν η πρεγκαμπαλίνη, έναντι του εικονικού φαρμάκου, ως συμπληρωματική θεραπεία σε open-label εσιταλοπράμη, θα έχει μεγαλύτερη μείωση των συμπτωμάτων άγχους και ταυτόχρονα καλύτερη νοητική ταχύτητα.
    E.2.2Secondary objectives of the trial
    1. To test whether depression symptoms respond better to the combination of pregabaline plus escitalopram, compared with escitalopram plus placebo.
    2. To assess the functioning of the Autonomic Nervous System (ANS) with the use of pupillometry.
    3. To test mental speed at a more superficial level, i.e. with an easier task.
    1. Να αξιολογηθεί εάν τα συμπτώματα της κατάθλιψης ανταποκρίνονται καλύτερα στο συνδυασμό της πρεγκαμπαλίνης με εσιταλοπράμη, έναντι της εσιταλοπράμης με εικονικό φάρμακο.
    2. Η αξιολόγηση της λειτουργίας του αυτόνομου νευρικού συστήματος (AΝΣ) με τη χρήση μετρήσεων της διαμέτρου της κόρης του οφθαλμού.
    3. Να εξεταστεί η νοητική ταχύτητα σε ένα πιο επιφανειακό επίπεδο, δηλαδή με ένα πιο εύκολο έργο.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Generalized Anxiety Disorder (GAD) according to DSM-IV-TR diagnostic criteria
    2. Major Depressive episode (MD) according to DSM-IV-TR diagnostic criteria
    3. Patients already receiving esitalopram.
    4. Male or female patients, aged between 18-65 years of age
    5. Signed and dated patients’ informed consent received from patients who are able to understand and comply with study requirements.
    1. Γενικευμένη Αγχώδης Διαταραχή (ΓΑΔ) σύμφωνα με τα DSM-IV-TR διαγνωστικά κριτήρια.
    2. Μείζων καταθλιπτικό επεισόδιο (ΜΚ) σύμφωνα με τα DSM-IV-TR διαγνωστικά κριτήρια.
    3. Ασθενείς που ήδη λαμβάνουν εσιταλοπράμη.
    4. Άνδρες ή γυναίκες άνω των 18-65 ετών.
    5. Υπογεγραμμένη και χρονολογημένη έγγραφη συγκατάθεση κατόπιν ενημέρωσης από ασθενείς που είναι σε θέση να κατανοήσουν και να συμμορφωθούν με τις απαιτήσεις της μελέτης.
    E.4Principal exclusion criteria
    1. Any other comorbid condition
    2. Abuse of alcohol or other substances at screening (excepting dependence being in total remission; excepting dependence on caffeine or nicotine), according to DSM-IV criteria
    3. Abuse of substances such as opiates, amphetamines, barbiturates, cocaine, cannabis, hallucinogens for a duration of four weeks before screening day, according to DSM-IV criteria
    4. Any DSM-IV-TR-defined psychic disorder that may affect the interpretation of results
    5. Female patients of reproductive age who do not apply any reliable contraceptive method and do not have a negative human chorionic gonadotropin (HCG) value at screening
    6. Patients who are in severe danger of suicide, or represent a danger to themselves and others in the investigator’s judgment
    7. Known hypersensitivity or lack of responsiveness to the trial drugs in the investigator’s judgment.
    1. Οποιαδήποτε άλλη συνυπάρχουσα πάθηση.
    2. Κατάχρηση αλκοόλ ή άλλων ουσιών κατά την ένταξη (εκτός από την εξάρτηση σε πλήρη ύφεση, και εκτός από την εξάρτηση στην καφεΐνη ή τη νικοτίνη), όπως ορίζεται από τα DSM-IV κριτήρια.
    3. Κατάχρηση ουσιών όπως τα οπιούχα, αμφεταμίνες, βαρβιτουρικά, η κοκαΐνη, κάνναβη, ή παραισθησιογόνα εντός 4 εβδομάδων πριν την ένταξη στη μελέτη, συμφώνα με τα κριτήρια DSM-IV.
    4. Οποιαδήποτε DSM-IV-TR ψυχική διαταραχή που μπορεί να επηρεάσει την ερμηνεία των αποτελεσμάτων.
    5. Γυναίκες ασθενείς με δυνατότητα τεκνοποίησης που δεν εφαρμόζουν μια αξιόπιστη μέθοδο αντισύλληψης και δεν έχουν αρνητικές τιμές της ανθρώπινης χοριακής γοναδοτροπίνης (HCG) κατά την ένταξη.
    6. Ασθενείς οι οποίοι, κατά τη γνώμη του ερευνητή, είναι σε σοβαρό κίνδυνο αυτοκτονίας ή παρουσιάζουν κίνδυνο για τον εαυτό ή τους άλλους.
    7. Γνωστή υπερευαισθησία ή έλλειψη ανταπόκρισης στα φάρμακα της μελέτης κατά την κρίση του ερευνητή.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the anxiety scale State-Trait Inventory form Y, STATE (STAI-S) and in the Trail Making Test – form B.
    Μεταβολή στην κλίμακα άγχους State-Trait Anxiety Inventory-Form Y, State (STAI-S) και στη Δοκιμασία Οπτικό-Νοητικής Ιχνηλάτησης (Trail Making Test -form B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study.
    Καθόλη τη διάρκεια της μελέτης.
    E.5.2Secondary end point(s)
    Change in the Center of Epidemiological Studies-Depression (CES-D) scale score;
    change in the Trail Making Test – form A;
    pupillometry: absolute pupil size at baseline;
    pupillometry: absolute pupil size at maximum constriction after single flash at 1 Hz;
    pupillometry: % of pupil size change after single flash at 1 Hz;
    pupillometry: absolute pupil size after a series of ten flashes at 1 Hz;
    pupillometry: % of pupil size change after a series of ten flashes at 1 Hz;
    pupillometry: ratio of pupil size change after single flash at 1 Hz, compared with pupil size change after a series of ten flashes at 1 Hz.
    Evaluation of possible adverse events with the use of the UKU scale.
    Μεταβολή στην κλίμακα του Κέντρου Επιδημιολογικών Ερευνών για την Κατάθλιψη (CES-D score).
    Μεταβολή στη Δοκιμασία Οπτικό-Νοητικής Ιχνηλάτησης (Trail Making Test -form Α).
    Μέτρηση διαμέτρου κόρης (απόλυτο μέγεθος της κατά την έναρξη), μέτρηση διαμέτρου κόρης (απόλυτο μέγεθος της κόρης κατά τη μέγιστη συστολή μετά από ένα flash φωτός), μέτρηση διαμέτρου κόρης (ποσοστιαία % μεταβολή στο μέγεθος της κόρης μετά από ένα flash φωτός, μέτρηση διαμέτρου κόρης (απόλυτο μέγεθος της κόρης στο δέκατο flash φωτός-1 Hz), μέτρηση διαμέτρου κόρης (ποσοστιαία % αλλαγή στο μέγεθος της κόρης μετά από 10 flashes φωτός-1 Hz) και μέτρηση διαμέτρου κόρης (αναλογία του μεγέθους της κόρης μετά από ένα flash με το μέγεθος της κόρης μετά από 10 flashes φωτός (1 Hz).
    Αξιολόγηση των πιθανών ανεπιθύμητων ενεργειών, μέσω της κλίμακας UKU.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study.
    Καθόλη τη διάρκεια της μελέτης.
    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 No
    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 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 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
    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 months15
    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: 60
    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 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.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    Depending on the patient's status, the Principal Investigator will advise the patient accordingly regarding therapeutic choices.
    Ανάλογα με την κατάσταση του ασθενή, ο θεράπων ιατρός θα συμβουλέψει τον ασθενή σχετικά με τις θεραπευτικές επιλογές.
    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 Decision2013-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-28
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