Study of Trazodone Once-a-Day for treatment of Depression in patients with breast cancer.
- Conditions
- Major Depressive DisorderMedDRA version: 21.1Level: LLTClassification code 10081270Term: Major depressive disorderSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2021-005007-12-BG
- Lead Sponsor
- Angelini Pharma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method