EUCTR2021-005007-12-BG进行中（未招募）1 期
Efficacy of Trazodone Once-a-Day for treatment of Major Depressive Disorder in patients with breast cancer. - TzOAD in breast cancer
Angelini Pharma S.p.A.0 个研究点目标入组 100 人开始时间: 2022年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
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