Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38958   clinical trials with a EudraCT protocol, of which   6398   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-000757-13
    Sponsor's Protocol Code Number:RGH-MD-54
    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:2016-05-12
    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 number2016-000757-13
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipolar I Depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Assess the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipolar I Depression
    A.4.1Sponsor's protocol code numberRGH-MD-54
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02670551
    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 Laboratories LLC, an Allergan Affiliate
    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 Laboratories, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    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 Yes
    D.2.1.1.1Trade name Vraylar (Cariprazine)
    D.2.1.1.2Name of the Marketing Authorisation holderForest Laboratories LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 1083076-69-0
    D.3.9.2Current sponsor codeRGH-188 HCL
    D.3.9.3Other descriptive nameCARIPRAZINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB122927
    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: 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 Yes
    D.2.1.1.1Trade name Vraylar (Cariprazine)
    D.2.1.1.2Name of the Marketing Authorisation holderForest Laboratories LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 1083076-69-0
    D.3.9.2Current sponsor codeRGH-188 HCL
    D.3.9.3Other descriptive nameCARIPRAZINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB122927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Bipolar I Depression
    E.1.1.1Medical condition in easily understood language
    Bipolar I Depression
    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 SOC
    E.1.2Classification code 10037175
    E.1.2Term Psychiatric disorders
    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
    The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3.0 mg/day relative to placebo in patients with bipolar I depression.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria to be assessed at Visit 1 (Screening)
    1. Written informed consent, signed, obtained from the patient before the initiation of any study-specific procedures
    2. Male or female patients 18 to 65 years of age, inclusive
    3. Currently meet the DSM-5 criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not
    exceeding 12 months in duration
    4. Currently treated as an outpatient at the time of enrolment
    5. A verified previous manic or mixed episode. Verification must include one of the following sources:
    a. Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania
    b. Hospital records/Medical records
    c. Patient report corroborated by caretaker or previous or current treating clinician
    6. 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
    7. HAMD-17 item 1 score ≥ 2
    8. CGI-S score ≥ 4
    9. Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
    10. Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the PI

    Inclusion criteria to be assessed at Visit 2 (Baseline)
    11. Continue to meet Visit 1 inclusion criteria
    E.4Principal exclusion criteria
    Exclusion criteria to be assessed at Visit 1 (Screening)
    Psychiatric Criteria
    1. Young Mania Rating Scale (YMRS) total score > 12
    2. Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
    3. Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
    4. History of meeting DSM-5 criteria for Dementia, amnesic, or other cognitive disorder, Schizophrenia, schizoaffective, or other psychotic disorder or Mental retardation
    5. DSM-5–based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
    6. History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the 6 months before Visit 1
    7. Positive result on blood alcohol test or urine drug screen for any prohibited medication.
    8. History of intolerance or hypersensitivity to cariprazine or to rescue medications
    9. History of nonresponse in the current depressive episode to 2 or more antidepressant trials of adequate dose and treatment duration (at least 6 weeks at an adequate dose based on package insert recommendations) with or without mood stabilizers
    10. Treatment failure of quetiapine, lurasidone, or Symbyax (fluoxetine and olanzapine) in the treatment of bipolar depression during the current depressive episode
    11. At imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
    12. A patient who, in the PI’s judgment, cannot be safely treated as an outpatient
    13. Suicide risk as determined by meeting the criteria listed in the protocol
    Treatment-Related Criteria:
    14. Electroconvulsive therapy in the 3 months before Visit 1
    15. Previous lack of response to electroconvulsive therapy
    16. Treatment with a depot antipsychotic drug within 6 months prior to Visit 1
    17. Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
    18. Requiring concomitant treatment as per the protocol
    19. Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
    20. Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
    21. Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
    22. Initiation or termination of phototherapy within the 2 weeks before screening, or plans to initiate same during the course of the study
    Other Medical Criteria:
    23/24. Male/female patients who do not follow the contraception requirements of the study.
    25. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
    26. Any cardiovascular disease that is clinically significant, unstable, or decompensated and other CV conditions as listed in the protocol
    27. Hypothyroidism or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 1 month before Visit 1
    28. Hemoglobin A1c ≥ 6.5% on screening
    29. Psychiatric symptoms possibly secondary to any other general medical condition
    30. Gastric bypass or any condition that would be expected to affect drug absorption
    31. History of seizure disorder, with the exception of febrile seizure, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes toward a risk of seizure
    32. Known history of cataracts or retinal detachment
    33. Known human immunodeficiency virus infection
    34. Positive hepatitis C antibody on screening
    35. Positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M
    36. Screening liver enzyme test results > 2 x ULN or total bilirubin > 1 x ULN
    37. History of tardive dyskinesia (except for mild cases attributed to use of conventional agents), or neuroleptic malignant syndrome
    Other Criteria:
    38. Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center
    39. Inability to speak, read, or understand the local language sufficiently to understand the nature of the study, to provide signed written informed consent, or to allow the completion of all study assessments
    40. Unable or unlikely to comply with the study protocol or unsuitable for any other reason, as judged by the PI
    Exclusion criteria to be assessed at Visit 2 (Baseline)
    41. YMRS total score > 12
    42. Suicide risk, as determined by meeting the criteria listed in the protocol
    43. Any other Visit 1 exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will primarily be measured via the use of the clinician rated scales; Montgomery-Åsberg Depression Rating Scale (MADRS)

    Safety will be measured via adverse event recording, clinical laboratory parameters (hematology, chemistry, urinalysis, prolactin), vital sign parameters, electrocardiograms, physical examinations, Young Mania Rating Scale (YMRS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Columbia–Suicide Severity Rating Scale (C-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various points throughout the study.
    E.5.2Secondary end point(s)
    Clinical Global Impression-Severity
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various points throughout the study.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Bulgaria
    Estonia
    Lithuania
    Poland
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 480
    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 per normal treatment
    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 Decision2016-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-19
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA