Section of Psychiatry, University of Ferrara, Italy.
Ann Gen Psychiatry. 2009 May 29;8:14. doi: 10.1186/1744-859X-8-14.
Factors Influencing Depression Endpoints Research (FINDER) is a 6-month, prospective, observational study carried out in 12 European countries aimed at investigating health-related quality of life (HRQoL) in outpatients receiving pharmacological treatment for a first or new depressive episode. Baseline characteristics of patients enrolled in Italy are presented.
All treatment decisions were at the discretion of the investigator. Data were collected at baseline and after 3 and 6 months of treatment. Baseline evaluations included demographics, medical and psychiatric history, and medications used in the last 24 months and prescribed at enrollment. The Hospital Anxiety and Depression Scale (HADS), was adopted to evaluate depressive symptoms, while somatic and painful physical symptoms were assessed by using the Somatic Symptom Inventory (SSI) and a 0 to 100 mm visual analogue scale (VAS), HRQoL via 36-item Short Form Health Survey (SF-36), and the European Quality of Life 5-Dimensions (EQ-5D) instrument.
A total of 513 patients were recruited across 38 sites. The mean +/- standard deviation (SD) age at first depressive episode was 38.7 +/- 15.9 years, the mean duration of depression 10.6 +/- 12.3 years. The most common psychiatric comorbidities in the previous 24 months were anxiety/panic (72.6%) and obsessive/compulsive disorders (13.4%), while 35.9% had functional somatic syndromes. Most patients (65.1%) reported pain from any cause. Monotherapy with selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) was prescribed at enrollment in 64.5% and 6.4% of the cases, respectively. The most commonly prescribed agents were sertraline (17.3%), escitalopram (16.2%), venlaflaxine (15.6%) and paroxetine (14.8%). The mean HADS subscores for depression and anxiety were 13.3 +/- 4.2 and 12.2 +/- 3.9, respectively; 76.4% of patients could be defined as being 'probable cases' for depression and 66.2% for anxiety. The mean total score of VAS-pain in the last week was 42.9 +/- 27.1, with highest scores reported in the 'interference of pain with daily activities' and in 'amount of time patient was awake and had pain'. From SF-36, the worst health status was found for role limitations due to emotional problem, mental health and social functioning. A mean score < 50 (that is, below the standardised population norm) was also found in all remaining domains. The SF-36 summary scores and EQ-5D (health status and VAS) were lower in patients with moderate/severe pain than in those with no or mild pain.
The baseline results of patients enrolled in the FINDER study in Italy show clinical and functional impairments, and poor HRQoL. The results obtained after 6 months of therapy will permit better understanding the effects of different variables on clinical outcomes and HRQoL.
影响抑郁终点研究的因素(FINDER)是一项为期 6 个月的前瞻性观察研究,在 12 个欧洲国家进行,旨在调查首次或新发抑郁发作接受药物治疗的门诊患者的健康相关生活质量(HRQoL)。本文介绍了在意大利入组患者的基线特征。
所有治疗决策均由研究者自行决定。数据在基线和治疗后 3 个月和 6 个月收集。基线评估包括人口统计学、医疗和精神病史,以及过去 24 个月内使用的和入组时开的药物。采用医院焦虑和抑郁量表(HADS)评估抑郁症状,躯体和疼痛性躯体症状采用躯体症状量表(SSI)和 0 至 100mm 视觉模拟量表(VAS)评估,使用 36 项简明健康调查量表(SF-36)和欧洲五维健康量表(EQ-5D)评估 HRQoL。
共在 38 个地点招募了 513 名患者。首次抑郁发作的平均年龄为 38.7±15.9 岁,平均抑郁持续时间为 10.6±12.3 年。在过去 24 个月中最常见的合并精神疾病为焦虑/惊恐症(72.6%)和强迫症(13.4%),35.9%的患者存在功能性躯体综合征。大多数患者(65.1%)报告有任何原因引起的疼痛。在入组时,单药治疗分别使用选择性 5-羟色胺再摄取抑制剂(SSRIs)和三环类抗抑郁药(TCAs)的比例为 64.5%和 6.4%。最常开的药物是舍曲林(17.3%)、艾司西酞普兰(16.2%)、文拉法辛(15.6%)和帕罗西汀(14.8%)。HADS 抑郁和焦虑亚量表的平均得分分别为 13.3±4.2 和 12.2±3.9,分别有 76.4%和 66.2%的患者可以被定义为“可能的病例”。过去一周 VAS 疼痛总分平均为 42.9±27.1,在“疼痛对日常活动的干扰”和“患者醒着和疼痛的时间”方面得分最高。从 SF-36 来看,情绪问题、心理健康和社会功能的角色限制导致的健康状况最差。在所有其他领域也发现了低于 50(即低于标准化人群正常值)的平均评分。在中度/重度疼痛患者中,SF-36 综合评分和 EQ-5D(健康状况和 VAS)的得分低于无或轻度疼痛患者。
意大利 FINDER 研究入组患者的基线结果显示存在临床和功能障碍,以及较差的 HRQoL。治疗 6 个月后获得的结果将更好地理解不同变量对临床结局和 HRQoL 的影响。