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    Summary
    EudraCT Number:2021-005007-12
    Sponsor's Protocol Code Number:039(C)MD21046
    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:2022-11-15
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-005007-12
    A.3Full title of the trial
    Efficacy of Trazodone Once-a-Day for treatment of Major Depressive Disorder in patients with breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Trazodone Once-a-Day for treatment of Depression in patients with breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    TzOAD in breast cancer
    A.4.1Sponsor's protocol code number039(C)MD21046
    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 SponsorAngelini Pharma S.p.A.
    B.1.3.4CountryItaly
    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 supportAngelini Pharma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAngelini Pharma S.p.A.
    B.5.2Functional name of contact pointGlobal Medical Department
    B.5.3 Address:
    B.5.3.1Street AddressViale Amelia, 70
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00181
    B.5.3.4CountryItaly
    B.5.4Telephone number+390691045364
    B.5.5Fax number+390678332453
    B.5.6E-maillaura.pellegrini@angelinipharma.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 Trittico XR 150 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Pharma Bulgaria EOOD
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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 nameTrittico XR 150 mg prolonged-release tablets
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTRAZODONE
    D.3.9.1CAS number 25332-39-2
    D.3.9.2Current sponsor codeAF 1161
    D.3.9.3Other descriptive nameTrazodone Hydrochloride
    D.3.9.4EV Substance CodeSUB11224MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Trittico XR 300 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Pharma Bulgaria EOOD
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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 nameTrittico XR 300 mg prolonged -release tablets
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTRAZODONE
    D.3.9.1CAS number 25332-39-2
    D.3.9.2Current sponsor codeAF 1161
    D.3.9.3Other descriptive nameTrazodone Hydrochloride
    D.3.9.4EV Substance CodeSUB11224MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    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
    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 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 assess the efficacy of trazodone once-a day monotherapy in improving
    depression symptoms in patients with breast cancer and co-morbid major depressive disorder after 8-week treatment period.
    E.2.2Secondary objectives of the trial
    To assess the patient’s evaluation of depressive symptoms, functional recovery including cognitive and behavioural responses, quality of life, the compliance of antidepressant treatment, and safety over the 12-weeks study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients of any ethnic origin between 18 and 64 years of age (limits included).
    2. Outpatients with non-metastatic breast cancer under endocrine therapy. The primary diagnosis of breast cancer must be confirmed by appropriate clinical and instrumental assessment.
    3. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis, experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at Baseline Visit.
    4. Patients eligible to start treatment with trazodone once-a-day monotherapy at Baseline Visit. In case of switch from other antidepressant drug, the related tapering schedule should be completed at the time of study inclusion.
    5. Women of childbearing potential and women with no menses for a period <12 months must have a negative pregnancy test at Baseline Visit and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormonereleasing
    System (IUS) in combination with male condom, bilateral tubal
    occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
    - Woman of childbearing potential (WOCBP): i.e., fertile, following
    menarche and until becoming post-menopausal, unless permanently
    sterile. Permanent sterilization methods include hysterectomy,
    bilateral salpingectomy and bilateral oophorectomy.
    - A postmenopausal state is defined as no menses for 12 months
    without an alternative medical cause.
    6. Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures.
    E.4Principal exclusion criteria
    1.Patients who meet any of the contraindications to the administration of trazodone once-a-day according to the approved local SmPC.
    2. Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication.
    3. Patients with locally advance or metastatic breast cancer or receiving
    adjuvant chemotherapy.
    4. Concomitant treatment with other antidepressant drugs (use is forbidden for the whole study duration) and/or proved resistance to the trazodone once a- day monotherapy.
    5. Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders or mental disorders due to a general medical condition.
    6. Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative disease, or other relevant condition (e.g. heart disease) that, in the opinion of the Investigator, might compromise participation in the study.
    7. Patients who are at risk of suicide defined by a score ≥4 in MADRS item #10 at Baseline Visit.
    8. Women during pregnancy or lactation period.
    9. Clinically significant abnormalities on physical examination, vital signs and/or laboratory values (as assessed per routine clinical practice) at Baseline Visit which, in the opinion of the Investigator, could interfere with the study procedures or endpoints evaluation.
    10. Patients with known cardiovascular disease including those associated to the prolongation of the QT interval (e.g. QTcF value higher than 450 msec for male and QTcF value higher than 470 msec for female)
    11. Suspicious or confirmed COVID-19 infection according to the patient’s symptoms at the time of Baseline Visit.
    12. Inability to comply with the protocol requirements (i.e. uncooperative attitude, inability to return to study visits, unlikelihood of completing the clinical study).
    13. Subject involved in the conduct of the study (e.g. Investigator or her deputy, first grade relatives, pharmacist, assistant or other personnel).
    14. Participation to an interventional clinical trial within 3 months of Baseline Visit.
    E.5 End points
    E.5.1Primary end point(s)
    The mean change in Montgomery-Asberg Depression Rating
    Scale (MADRS) score from Baseline Visit to Visit 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3
    E.5.2Secondary end point(s)
    -mean changes in MADRS score from Baseline Visit to Visits 1, 2 and 4
    -changes in the distribution of Clinical Global Impression (CGI) from
    Baseline Visit to Visits 1, 2, 3 and 4
    -mean changes in Brief Symptom Inventory modified version (BSI-18
    MOD) total score from Baseline Visit to Visits 1, 2, 3 and 4
    -changes in the distribution of Insomnia Severity Index (ISI) from Baseline Visit to Visits 1, 2, 3 and 4
    -mean changes in Biological Rhythms Interview for Assessment in
    Neuropsychiatry (BRIAN) total score from Baseline Visit to Visit 4
    - mean changes in Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
    total score from Baseline Visit to Visits 3 and 4
    - changes in EuroQuality of Life 5 dimensions – 5 level (EQ-5D-5L) and
    mean changes in the Visual Analogue Scale (VAS) from Baseline Visit to
    Visits 3 and 4 comparison between MADRS, BSI-18 MOD, Mini-MAC and VAS of EQ-5D-5L at Baseline Visit, Visit 3 and Visit 4
    -compliance to antidepressant treatment (calculated as number of
    trazodone once-a-day tablets taken by patient since Baseline Visit until
    the last day of medication)
    -changes in concomitant medications for treatment of depression over
    the 12-weeks study period
    - safety evaluation
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Visit 1,2 and 4
    -Visit 1,2,3 and 4
    -Visit 1,2,3 and 4
    -Visit 1,2,3 and 4
    -Visit 4
    -Visit 3 and 4
    -Visit 3 and 4
    -Visit 3 and 4
    -last day of medication
    -12 weeks
    -12 weeks
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state100
    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)
    Patients will be managed according to the clinical practice
    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 Decision2023-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-10
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