Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Depressive symptoms severity (MADRS)
研究概览
简要总结
TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 55 or older.
- •Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis.
- •Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment.
- •Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria.
- •Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week).
- •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 as per clinical judgement.
排除标准
- •Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.
- •Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication.
- •Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy.
- •Patients with 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.
- •Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study.
- •Patients participating in any interventional study in the 30 days prior to the enrolment visit.
- •Patients with ongoing pregnancy or breast-feeding at enrolment visit.
结局指标
主要结局
Depressive symptoms severity (MADRS)
时间窗: At 24 weeks from treatment
To describe the response in terms of depressive symptoms severity (as measured by Montgomery-Åsberg Depression Rating Scale \[MADRS\]) start among patients with moderate-severe MDD and with MCI treated with prolonged release trazodone. The Montgomery-Åsberg Depression Rating Scale (MADRS) is a widely used clinician-rated scale designed to measure the overall severity of core symptoms of depression in patients with MDD. It consists of 10 items: nine of the items are based upon patient report and one is on the rater's observation during the rating interview. MADRS items are rated on a 7-point scale, where 0 refers to the lack of the symptom and 6 refers to the most severe level of the symptom. The total score is the sum of the items and ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. The MADRS is completed by the Investigator at each scheduled visit and the results will be entered into the eCRF.
次要结局
- Depressive symptoms severity (MADRS)(At 12 weeks from treatment)
- Clinical response (CGI)(At 24 weeks from treatment)
- Cognitive functioning (MoCA)(At 24 weeks from treatment)
- Sleep quality (SQS)(At 24 weeks from treatment)
- To describe the response in terms of quality of life (EQ-5D-5L)(At 24 weeks from treatment)
- Absolute and relative frequency of patients(Over 24 weeks)
- Serious adverse events of prolonged release trazodone(Over 24 weeks)
- Drug related adverse events of prolonged release trazodone(Over 24 weeks)