Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
研究概览
简要总结
This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. This will address unmet medical needs of patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to respond adequately to initial treatment with an antidepressant and contribute to an understanding of the usual approaches that physicians adopt to monitor initial treatment efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013
- •Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks
- •Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.
排除标准
- •Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.
- •Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics
- •Patients with unstable general medical condition.
- •Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode).
结局指标
主要结局
Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
时间窗: up to 6 months
Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion.
次要结局
- Source of the patient's referral to a psychiatrist(up to 6 months)
- Doses of pharmacological agents used for augmentation(Up to 6 months)
- Pharmacotherapy strategy for the second line treatment(up to 6 months)
- International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation(Up to 6 months)