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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

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    Summary
    EudraCT Number:2018-003164-31
    Sponsor's Protocol Code Number:3111-302-001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003164-31
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CARIPRAZINE AS AN
    ADJUNCT TO ANTIDEPRESSANTS IN THE TREATMENT OF PATIENTS WITH
    MAJOR DEPRESSIVE DISORDER WHO HAVE HAD AN INADEQUATE
    RESPONSE TO ANTIDEPRESSANTS ALONE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to look into the safety and efficacy of
    cariprazine as an add-on medication in the treatment of major depressive
    disorder.
    A.4.1Sponsor's protocol code number3111-302-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03739203
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressGround Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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.3.4Pharmaceutical 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
    D.3.9.1CAS number 1083076-69-0
    D.3.9.2Current sponsor codeRGH-188, MP-214
    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 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.3.4Pharmaceutical 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
    D.3.9.1CAS number 1083076-69-0
    D.3.9.2Current sponsor codeRGH-188, MP-214
    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 typeup to
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Clinical 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    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
    To evaluate the efficacy, safety, and tolerability of cariprazine 1.5
    mg/day and 3 mg/day compared with placebo as an adjunctive
    treatment to ongoing antidepressant therapy (ADT) in patients with
    major depressive disorder (MDD) who have had an inadequate response
    to antidepressants alone
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent has been obtained
    2. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites])
    3. Patient is male or female 18 to 65 years of age, inclusive, at the time of consent
    4. Patient must be an outpatient at the time of Visit 1 (Screening)
    5. Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks to less than 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable
    6. Diagnosis of MDD confirmed through a formal adjudication process
    7. Patient demonstrates ability to follow study instructions and likely to complete all required visits
    8. In the current depressive episode, patient must have an inadequate response (< 50% improvement), to 1 to 3 antidepressants of adequate dose and adequate duration, as measured by the modified ATRQ. Adequate dose is defined as a dose above the minimum labeled dose (per package insert). Adequate duration is defined as continuous ADT treatment for at least 6 weeks, with a minimum of 3 of 6 weeks above the minimal dose
    9. Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Baseline (Visit 2)
    10. Patient must have a minimum score of 22 on the rater-administered Hamilton Depression
    Rating Scale–17 items (HAMD-17) at both Screening (Visit 1) and Baseline (Visit 2)
    11. Patient has a score of 2 or higher on Item 1 of the HAMD-17 rating scale at Visits 1 and 2
    12. Patient has normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results from Screening (Visit 1), or abnormal results that are judged to be clinically insignificant by the investigator
    13. Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study and for 12 weeks after the last dose of investigational product
    14. Women of childbearing potential (only) must have a negative qualitative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2
    E.4Principal exclusion criteria
    1. Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias
    2. History of manic or hypomanic episodes
    3. Patients with a YMRS score ≥ 12
    4. Patient has a history of meeting DSM-5 diagnosis for any substance-related disorders
    (ie, use disorders except caffeine- and tobacco-related) within the 3 months before Visit 1 (Screening)
    5. Patient had a positive result at Visit 1 (Screening) from the urine drug screen (UDS) for any prohibited drugs. Exception: patients with a positive UDS at Visit 1 for opiates, cannabinoids, amphetamines, barbiturates, or benzodiazepines may be allowed in the
    study provided:
    a. The drug was used for a legitimate medical purpose;
    b. The drug can be discontinued prior to further participation in the study (except for benzodiazepines which may be continued if the patient has been taking a stable dose [ie, lorazepam up to 2 mg/day or its benzodiazepine equivalent] for at least 1 month prior to Visit 1 (Screening) or if used as rescue during washout);
    and
    c. A repeat UDS must be performed prior to Visit 2 and must be negative, except benzodiazepine use as described in 4(b) and Section 4.5.3
    6. The patient represents a suicide risk, as determined by meeting any of the following
    criteria:
    a. Patient made a suicide attempt within the past year prior to Visit 1 (Screening)
    b. Patient had a score of 4 or greater on Item 10 of the MADRS at Visit 1
    (Screening) or Visit 2 (Baseline)
    c. Patient had a score of 3 or greater on Item 3 of the HAMD-17 at Visit 1
    (Screening) or Visit 2 (Baseline)
    d. Patient is at significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia–Suicide Severity Rating Scale (C-SSRS) at Visit 1 (Screening) or Visit 2 (Baseline)
    7. Patient is at imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
    8. Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications
    Treatment-Related Criteria:
    9. Per ATRQ, patient failed to respond to > 3 trials of ADTs given at an adequate dose (as
    defined by the ADT package insert) and duration of ≥ 6 weeks during the present episode
    10. Patient was treated with monoamine oxidase inhibitors in the current episode
    11. Patient has history of treatment with clozapine > 50 mg/day or any depot antipsychotic at any time prior to Visit 1 (Screening)
    12. Patient has history of treatment with esketamine, electroconvulsive therapy, 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) or previous lack of response to treatment with esketamine, electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation
    13. Patients who require concomitant treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or any CYP3A4 inducers. If applicable, these treatments must be discontinued at least 10 days prior to Visit 2 (Baseline)
    14. Patient requires concomitant treatment with any prohibited medication, supplement, or herbal product including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component (for exceptions allowed for concomitant treatments, refer to Sections 4.5.2 and 4.5.3)
    15. Participation in any clinical study, involving experimental or investigational drugs or devices during the study or within 3 months before Visit 1 (or at least 5 half-lives of the drug, whichever is longer)
    16. Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1 (Screening), or plans to initiate, terminate, or change such therapy during the course of the study
    17. Female patients who are pregnant, planning to become pregnant during the course of the study, or are currently lactating
    18. Any concurrent medical condition that, in the judgment of the investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
    19. Any cardiovascular disease that is clinically significant, unstable, or decompensated including history of congenital QTc prolongation or QTc prolongation (screening ECG with QTcF ≥ 450 msec for men and QTcF ≥ 470 msec for women)
    20. Any disease (eg, hypertension) that is clinically unstable or
    decompensated, based on the investigator's judgment
    21. Newly diagnosed or clinically uncontrolled hypo- or hyperthyroidism as evident on clinical laboratory test results at Visit 1. Patients diagnosed previously with hypo- or hyperthyroidism have to be stabilized on appropriate pharmacotherapy with no change in dosage for at least 1 month before Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter will be the change from baseline to Week 6 in the MADRS total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (Visit 2) to Week 6 (Visit 6) or early patient
    discontinuation from the study (Early Termination visit)
    E.5.2Secondary end point(s)
    Additional efficacy parameters will include the following:
    - Change from baseline in the CGI-S score
    - CGI-I score
    - CGI-I response (CGI-I score ≤ 2)
    - MADRS response (≥ 50% reduction from baseline in MADRS total
    score)
    - MADRS remission (MADRS total score ≤ 10)
    - Change from baseline in the HAMD-17 total score
    - Change from baseline in the HAM-A total score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Postbaseline visits described in the Table 1 of the protocol.
    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 No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.2.3.1Comparator description
    Adjunt to antidepressant treatment of Major Depressive Disorder
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Canada
    Serbia
    United States
    Finland
    Poland
    Slovakia
    Czechia
    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 months1
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days21
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state121
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 298
    F.4.2.2In the whole clinical trial 750
    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)
    After completion of Visit 6/ET, patients will receive treatment for their
    MDD as deemed necessary by the Investigator or designee.
    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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-06
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