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    Summary
    EudraCT Number:2021-001192-17
    Sponsor's Protocol Code Number:ITI-007-501
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-29
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2021-001192-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
    Randomizované, dvojito zaslepené, placebom kontrolované, multicentrické skúšanie na zhodnotenie účinnosti a bezpečnosti lumateperónu ako prídavnej liečby u pacientov s depresívnou poruchou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy and Safety of Lumateperone as Add on Therapy in the Treatment of Patients with Major Depressive Disorder
    A.4.1Sponsor's protocol code numberITI-007-501
    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.
    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.
    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.
    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.5.4Telephone number+1646-440-9333
    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 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 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 INN lumateperone tosylate (salt); lumateperone (free base)
    D.3.9.1CAS number 1187020-80-9
    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 number42
    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
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025458
    E.1.2Term Major depressive disorder, recurrent episode, moderate degree
    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
    To evaluate the efficacy of lumateperone 42 mg administered once daily compared withplacebo as adjunctive treatment to antidepressant therapy in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing antidepressant therapy (ADT) as measured by change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to ADT in patients with MDD who have an inadequate response to ongoing ADT as measured by change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S).

    Safety Objectives
    The safety objective of this study is to determine the safety and tolerability of lumateperone 42 mg administered orally once daily compared with that of placebo in patients with MDD who have an inadequate response to ongoing ADT as assessed by AEs; clinical laboratory results; vital sign measures; ECG results; suicidality as assessed by the C-SSRS; and extrapyramidal symptoms (EPS) as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria
    1. Provides written informed consent;
    2. Male or female patients between the ages of 18 and 65 years, inclusive;
    3. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor- approved rater using the MINI and meets all of the following criteria:
    a. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening (Visit 1);
    b. Has at least moderate severity of illness based on rater- administered MADRS total score ≥ 24 at Screening (Visit 1) and at Baseline (Visit 2);
    c. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2);
    d. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥14 at Screening (Visit 1) and at Baseline (Visit 2);
    e. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
    4. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:
    a. citalopram/escitalopram
    b. fluoxetine
    c. paroxetine
    d. sertraline
    e. duloxetine
    f. levomilnacipran/milnacipran (if locally approved for MDD)
    g. venlafaxine/desvenlafaxine
    h. bupropion
    I. vilazodone
    j. vortioxetine
    All Inclusion Criteria are presented in Section 6.3.1. of the enclosed protocol
    E.4Principal exclusion criteria
    Main Exclusion Criteria
    Patients who meet any of the following exclusion criteria will not be able to participate in the study:
    1. Within the patient’s lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
    a. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
    b. Bipolar Disorder;
    2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
    a. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
    b. Eating disorder;
    c. Substance use disorders (excluding nicotine);
    d. Personality disorder of sufficient severity to have a major impact on the patient’s psychiatric status;
    e. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
    3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2);
    4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2);
    5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
    a. At Screening (Visit 1), the patient scores “yes” on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline (Visit 2), the patient scores “yes” on Suicidal Ideation Items 4 or 5 since the Screening Visit;
    b. At Screening (Visit 1), the patient has had 1 or more suicide attempts within 2 years prior to Screening;
    c. At Screening (Visit 1) or Baseline (Visit 2), the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
    d. The patient is considered to be in imminent danger to him/herself or others.
    6. The patient has a first MDE at age 60 years or older. All Exclusion Criteria are presented in Section 6.3.2. of the enclosed protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change from baseline to Day 43 in the MADRS total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (Visit 2) to Day 43 (Visit 8)
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the, change from baseline to Day 43 in the CGI-S score.

    Additional efficacy analysis are included, below:
    Analysis of additional efficacy parameters will be based on the mITT population for the on-treatment effect and include the following:
    - 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 ≤ 10 at Day 43;
    - By-visit mean change from baseline in the MADRS total score;
    - By-visit mean change from baseline in the GAD-7 total score;
    - By-visit mean change from baseline in CGI-S score;
    - Change from baseline in MADRS individual item scores at each assessment time point, including Day 43
    Supportive analyses of the on-treatment effects of the additional efficacy endpoints will also be performed based on the ITT Population using all efficacy data, including assessments collected after patients stopped study treatment, except those assessed after starting a new ADT.

    Safety endpoints:
    Safety analyses will be performed using the Safety Population. The safety parameters will include AEs, clinical laboratory, vital signs, ECG, and EPS (AIMS, BARS, and SAS) and C-SSRS scales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoint: from Baseline (Visit 2) to Day 43 (Visit 8) in CGI-S score.
    Additional efficacy parameters: every visit
    Safety: every visit
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Czechia
    Hungary
    Slovakia
    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
    Last patient last visit
    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 days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial days18
    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: 465
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 244
    F.4.2.2In the whole clinical trial 470
    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)
    return to the standard of care
    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 Decision2022-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-27
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