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    Summary
    EudraCT Number:2011-005179-18
    Sponsor's Protocol Code Number:RGH-MD-75
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-29
    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 ConcernedEstonia - SAM
    A.2EudraCT number2011-005179-18
    A.3Full title of the trial
    A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as
    Adjunctive Therapy In Major Depressive Disorder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant
    Therapy in Major Depressive Disorder
    A.4.1Sponsor's protocol code numberRGH-MD-75
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01469377
    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 SponsorForest Research Institute, 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 supportForest Research Institute, USA
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGedeon Richter Plc
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Limited
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus, Rosebank
    B.5.3.2Town/ cityLivingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEudraCT_Info@quintiles.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 No
    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 nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 2
    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 No
    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 nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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.IMP: 3
    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 No
    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 nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.IMP: 4
    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 No
    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 nameCariprazine
    D.3.2Product code RGH-188
    D.3.4Pharmaceutical form Capsule
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.0
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Major Depressive 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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10025463
    E.1.2Term Major depressive disorder, single episode
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the efficacy, safety, and tolerability of cariprazine adjunctive to ADT in patients with major depressive disorder who have an inadequate response to ADT.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in the study, patients must meet the
    following criteria:
    1. Written informed consent, signed or thumbprinted (only if allowed by
    local
    regulations), obtained from the patient before the initiation of any
    study-specific
    procedures
    2. Male or female outpatients 18 to 65 years of age, inclusive
    3. Currently meet the DSM-IV-TR criteria for MDD without psychotic
    features based
    on the Structured Clinical Interview for Diagnostic Statistic Manual of
    Mental Health
    Disorders, Fourth Edition (SCID), with a current major depressive
    episode of at least
    8 weeks and not exceeding 24 months in duration at Visit 1
    4. Ongoing inadequate response to protocol allowed ADT (bupropion,
    citalopram,
    desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline,
    venlafaxine, or
    vilazodone) administered at adequate dose and duration in accordance
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    with the
    respective package insert, documented in the Antidepressant Treatment
    History Form
    (ATHF) with a resistance rating of ≥ 3 and a global confidence score of ≥
    3
    5. Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥
    22 at both
    Screening (Visit 1) and Baseline (Visit 2)
    6. Normal physical examination findings, clinical laboratory results, and
    electrocardiogram (ECG) results from Screening (Visit 1) or abnormal
    findings
    judged not clinically significant by the PI and documented as such in the
    eCRF
    7. Body mass index between 18 and 40, inclusive
    8. If female of child bearing potential, have a negative serum β-human
    chorionic
    gonadotropin (β-hCG]) pregnancy test
    E.4Principal exclusion criteria
    Psychiatric Criteria:
    1. Principal DSM-IV-TR–based diagnosis of an axis I disorder, other than
    MDD, or
    any axis I disorder other than MDD that was the primary focus of
    treatment within
    6 months before Visit 1 (secondary diagnoses of comorbid generalized
    anxiety
    disorder, social anxiety disorder, or specific phobias are acceptable)
    2. History of meeting DSM-IV-TR criteria for:
    a. Any depressive episode with psychotic or catatonic features
    b. Any manic, hypomanic or mixed episode, including bipolar disorder
    and
    substance-induced (eg, antidepressant-induced) manic, hypomanic or
    mixed
    episode
    c. Schizophrenia, schizoaffective, or other psychotic disorder
    d. Panic disorder, with or without agoraphobia
    e. Obsessive-Compulsive disorder
    f. Bulimia or Anorexia Nervosa
    g. Dementia, amnesic, or other cognitive disorder
    h. Mental retardation
    3. Meeting full DSM-IV-TR criteria for MDD "with seasonal pattern" AND
    the
    patient's season of remission would occur during the study.
    4. DSM-IV-TR–based diagnosis of borderline or antisocial personality
    disorder or other
    axis II disorder of sufficient severity to interfere with participation in
    this study
    5. History of meeting DSM-IV-TR criteria for alcohol or substance abuse
    or dependence
    (other than nicotine or caffeine) within the 6 months before Visit 1
    6. Positive result on blood alcohol test or for any prohibited medication
    on the urine
    drug screen with the following stipulations:
    ○ Patients with a positive urine drug screen for cannabinoids,
    barbiturates, opiates,
    amphetamines, or benzodiazepines may be allowed in the study provided
    that the
    drug was used for a legitimate medical purpose and the use of such
    products can
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    be discontinued (documented by a negative repeat test) before
    participation
    beyond screening
    ○ Medically appropriate episodic use (up to 3 days) of narcotic analgesics
    for acute
    medical indications is allowed
    ○ Discussion with Medical Monitor is recommended in any potential
    exception
    listed above
    ○ Positive results for methadone, phencyclidine, and cocaine are
    exclusionary with
    no exceptions
    7. Suicide risk, as determined by meeting any of the following criteria:
    ○ A suicide attempt within the past year
    ○ Significant risk, as judged by the PI, based on the psychiatric interview
    or
    information collected in the Columbia–Suicide Severity Rating Scale (CSSRS)
    at
    Visit 1 or Visit 2
    ○ MADRS Item 10 score ≥ 5 at Visit 1 or Visit 2
    8. At imminent risk of injuring self or others or causing significant
    damage to property,
    as judged by the PI
    9. Requires hospitalization
    Treatment-Related Criteria:
    10. Treatment refractory depression as defined by:
    ○ Failure to respond (< 50% reduction in depressive symptoms) to ≥ 3
    ADTs
    given at adequate dose (as defined by the ADT package insert) and
    duration of
    > 6 weeks during the present episode
    ○ History of inadequate response to ECT, a monoamine oxidase inhibitor,
    or
    adjunctive treatment with an antipsychotic
    11. Having a history of treatment with clozapine or any depot
    antipsychotic (exception:
    episodic use of clozapine at doses ≤ 150 mg/day for the treatment of
    insomnia)
    12. Having received any antipsychotic, anticonvulsant/mood stabilizer,
    anxiolytic,
    benzodiazepine, or other ADT augmentation agent (eg, T3 [except as
    treatment for
    thyroid condition], 2nd antidepressant, etc.) within 1 week or 5 half lives
    of the
    medication, whichever is longer, prior to Visit 2; however, 4 weeks for
    T3, 2 weeks is
    required for monoamine oxidase inhibitors, lithium must be tapered and
    discontinued
    over a minimum of two weeks followed by a 1- week washout, and safe
    withdrawal
    from benzodiazepine treatment is left to the discretion of the principal
    investigator
    13. History of electroconvulsive therapy (ECT), vagus nerve stimulation,
    transcranial
    magnetic stimulation, or any experimental central nervous system
    treatment during
    the current episode or in the 6 months before Visit 1 (whichever is
    longer)
    14. Requiring concomitant treatment with any of the prohibited
    medications,
    supplements, or herbal products listed in Appendix III, including any
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    psychotropic
    drug or any drug with psychotropic activity or with a potentially
    psychotropic
    component, except for the following:
    ○ Eszopiclone, zolpidem, zolpidem extended-release, zopiclone or
    zaleplon for
    insomnia may be continued provided the medication has been used in a
    consistent
    manner for 4 weeks prior to enrollment. Following randomization these
    medications may be introduced as specified in the concomitant
    medication
    section.
    15. Requiring concomitant treatment with strong CYP3A4 inhibitors or
    inducers
    16. Prior participation in any investigational study of RGH-188 or
    cariprazine
    E.5
    E.5 End points
    E.5.1Primary end point(s)
    The Montgomery-Åsberg Depression Rating Scale

    The primary efficacy parameter will be the change from baseline in MADRS total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Week 8 (Visit 7)

    E.5.2Secondary end point(s)
    The Sheehan Disability Scale.

    The secondary efficacy parameter will be the change from baseline in SDS score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Week 8 (Visit 7)
    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 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 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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Ukraine
    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
    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: 810
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Psychiatric patient
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 810
    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)
    As identified in protocol
    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 Decision2012-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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