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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2019-004440-29
    Sponsor's Protocol Code Number:ITI-007-403
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-04
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-004440-29
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder
    A.4.1Sponsor's protocol code numberITI-007-403
    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 SponsorIntra-Cellular Therapies, Inc. (ITI)
    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 supportIntra-Cellular Therapies, Inc. (ITI)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntra-Cellular Therapies, Inc. (ITI)
    B.5.2Functional name of contact pointITI Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address430 East 29th Street, Suite 900
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10016
    B.5.3.4CountryUnited States
    B.5.6E-mailITCIclinicaltrials@itci-inc.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 CAPLYTA
    D.2.1.1.2Name of the Marketing Authorisation holder Intra-Cellular Therapies, Inc.
    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 nameLumateperone
    D.3.2Product code ITI-007
    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 INNLumateperone tosylate
    D.3.9.1CAS number 1187020-80-9
    D.3.9.2Current sponsor codeLumateperone tosylate
    D.3.9.3Other descriptive nameITI-007 tosylate, ITI-007, FP-212, IC200056 tosylate salt, ITI-11-tosylate
    D.3.9.4EV Substance CodeSUB191580
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 episodes (MDEs) associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) with mixed features or major depressive disorder (MDD) with mixed features
    E.1.1.1Medical condition in easily understood language
    Bipolar Depression or 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10004936
    E.1.2Term Bipolar depression
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10081270
    E.1.2Term Major depressive disorder
    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 primary objective of this study is to confirm the efficacy of lumateperone 42 mg administered orally once daily compared with that of placebo as measured by mean change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with bipolar depression with mixed features or MDD with mixed features.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective:
    The key secondary objective of this study is to confirm the efficacy of lumateperone 42 mg administered orally once daily compared with that of placebo as measured by mean change from baseline to Day 43 in Clinical Global Impression Scale–Severity (CGI-S) score in patients with bipolar depression with mixed features or MDD with mixed features

    Safety Objective:
    The safety objective of this study is to determine the safety and tolerability of lumateperone administered orally once daily compared with that of placebo in patients with bipolar depression and MDD as assessed by adverse events (AEs); clinical laboratory results; vital sign measures; electrocardiogram (ECG) results; suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); manic symptoms as assessed by the YMRS; and extrapyramidal symptoms (EPS) as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS) scales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements;
    2. Male and female patients between the ages of 18 and 75 years, inclusive, at the start of screening;
    3. Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for Bipolar I or Bipolar II Disorder with mixed features or MDD with mixed features, as confirmed by the Investigator or Sponsor-approved rater using the Mini-International Neuropsychiatric Interview (MINI) and meets all of the following 4 criteria:
    a. The start of the current MDE is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1);
    b. Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥24 and corresponding to a CGI-S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2);
    c. Has sufficient history and/or independent report (such as family member or outside practitioner) verifying that the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning;
    d. Has a rater-administered YMRS total score between 4 and 16, inclusive, at Screening (Visit 1) and Baseline (Visit 2).
    4. Has a body mass index (BMI) of 19–35 kg/m2, inclusive;
    5. Either must agree to use highly effective methods of birth control (defined as those, alone or in combination, that result in a failure rate less than 1 percent per year when used consistently and correctly) for at least 2 weeks prior to randomization (starting with signing informed consent) through the end-of-study follow-up visit or must be of non-childbearing potential (defined as either permanently sterilized or, if female, post-menopausal; the latter is defined as at least 1 year with no menses without an alternative medical explanation);
    6. In the opinion of the Investigator, the patient is willing and able to comply with study requirements, study visits, and to return to the clinic for follow-up evaluations as specified by the protocol.
    E.4Principal exclusion criteria
    1. The patient experiences a ≥ 25% decrease in the rater-administered MADRS total score between Screening (Visit 1) and Baseline (Visit 2);
    2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
    a. At Screening, the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to screening; or
    b. At Screening, the patient has had 1 or more suicidal attempts with reference to a 2-year period prior to screening; or
    c. At Baseline, the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to Screening; or
    d. At Screening or Baseline, scores ≥4 on Item 10 (suicidal thoughts) on the rater-administered MADRS; or
    e. Considered to be an imminent danger to himself/herself or others;
    3. The patient is pregnant or breast-feeding;
    4. Within 12 months of screening, the patient has a confirmed DSM-5 psychiatric diagnosis other than Bipolar Disorder or MDD;
    5. Patients who have experienced hallucinations, delusions, or any other psychotic symptomatology in the current depressive episode may be allowed as long as these symptoms are not attributable to a primary DSM-5 diagnosis other than Bipolar Disorder or MDD, as described in Exclusion Criterion #4;
    6. The patient has been hospitalized for mania associated with Bipolar I Disorder within 30 days of screening;
    7. The patient has received electroconvulsive therapy, vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the last 5 years or received more than 1 course of electroconvulsive therapy during his/her lifetime.
    8. For patients with bipolar depression, the patient has had at least 4 major depressive, manic, hypomanic, or mixed episodes during the previous year;
    9. The patient is considered treatment-resistant, defined as having a lifetime history of treatment resistance (no remission) to ≥ 2 treatments with medications approved for the treatment of MDD or medications approved for the treatment of bipolar depression at an adequate dose for an adequate duration;
    10. The patient is currently receiving formal cognitive behavioral therapy, or plans to initiate such therapy during the study;
    11. The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma;
    12. The patient has a positive test for drugs of abuse or alcohol at Screening or presents evidence of either withdrawal from or acute intoxication with cocaine, opiates, amphetamines, alcohol, barbiturates, or hallucinogens or similar compounds;
    13. The patient has used 1 of the following agents under the specified conditions:
    a. Any previous exposure to lumateperone or exposure to any investigational product within 3 months of the baseline visit or participation in the past 4 years in >2 clinical studies of an investigational product with a central nervous system indication;
    b. Any strong or moderate cytochrome P450 3A4 inhibitor or inducer within 7 days prior to the baseline visit;
    c. Use of any short-acting anxiolytic medications within 1 week of Baseline/Visit 2 or of long-acting anxiolytics within 5 half-lives of the baseline visit;
    d. Drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects within the last 28 days or 5 half-lives before the baseline visit;
    14. The patient has abnormal laboratory values or clinical findings at screening that are judged clinically significant;
    15. 12-lead ECG corrected QT interval using the Fridericia formula (QTcF) >450 msec for males or females, the Bazett formula (QTcB) >450 msec for males or >470 msec for females, and/or heart rate ≤ 50 bpm, or evidence of clinically significant bundle-branch blocks;
    16. The patient has clinically significant cardiovascular; endocrine; hepatic; renal; pulmonary; gastrointestinal; neurological; malignancy; pheochromocytoma; metabolic; psychiatric or other condition that might be detrimental to the patient if he/she participates in the study;
    17. The patient has a known history of HIV infection;
    18. The patient has a positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M at screening;
    19. The patient has a positive hepatitis C antibody at screening;
    20. The patient is unable to be safely discontinued from current antidepressant medication, mood stabilizers, anticholinergics, or other psychotropic medications;
    21. The patient is judged by the Investigator to be inappropriate for the study;
    22. The patient is an employee of the Investigator or study site, or immediate family of such employees, the Investigator, the Sponsor, or contract research organizations conducting the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline to Day 43 in MADRS total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline to Day 43
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the change from baseline to Day 43 in CGI-S score.

    The additional secondary efficacy endpoints are:
    • The proportion of patients who are treatment responders where response is defined as a ≥ 50% decrease from baseline in MADRS total score at Day 43;
    • The proportion of remitters where remission is defined as a MADRS total score ≤ 12 at Day 43;
    • By-visit mean changes from baseline in the MADRS total score;
    • By-visit mean changes from baseline in CGI-S score;
    • Change from baseline in MADRS individual item scores at each assessment time point, including Day 43.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As listed above.
    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 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) 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 trial2
    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 concerned10
    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 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
    United States
    Bulgaria
    Russian Federation
    Serbia
    Ukraine
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 450
    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)
    Normal standard of care will resume, once the study has completed.
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-30
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 21:19:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA