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抗抑鬱藥物臨床試驗註冊的特徵分析 : 以 臨床試驗註冊庫為研究對象

English Abstract

Objective Depression is a common illness characterized by high recurrence rate, high suicide rate and low recovery rate. WHO estimates that more than 350 million people worldwide suffer from depression. Medication is one of the main treatments for depression. However, it isn’t a highly effective method. And it probably causes recurrence, this research analyze the characteristic and relationship of antidepressant clinical trial. is a high functional, practicability and convenicence clinical trial database which the data is outgiving. Until 30/04/2015, there are 189,315 clinical trial data Registered. This database provided a good research platform the medical and public health. Methods This study intends to filter the antidepressants related clinical trials which were conducted in 2012 and 2013 from the database of, analyze the factors of the clinical trials selected and the relationship between them, as well as to elaborate the latest development tendency and features of clinical trials of antidepressants. Results Antidepressants clinical trials for Major Depressive Disorder account for 53.72% of the trials selected. For Age group, both account for 91.15%. The smallscale trial with the enrollment between 0-100 candidates accounts for 67.71%. For primary purpose, treatment account for 77.6%. Regarding statistic, the variable elements associated with research fund include: Conditions, Age group, Trial phase, Enrollment and Primary purpose, and those associated with trial phases include: Gender,Age group, Enrollment, Endpoint classification, Primary purpose, Masking and Research fund. Conclusion After analysis the 192 antidepressants clinical trial in 2012-2013 from, this study analysis factors of clinical trial and their characteristics, especially in different funding source and phase, and also make some suggestion to, hope this study as a high quality evidence for medical decision making.

Chinese Abstract

目的及方法 抑鬱症是一種高發病率、高自殺率及低治療率的常見疾病,WHO 估計全球約有 3.5 億名患者,藥物是治療抑鬱症的主要方法之一,因現時藥物 治療效果未達理想水平,且容易導致抑鬱復發。 資料庫是一個功能性、實用性及便利性較高的臨床試驗資料庫, 資料庫內容是公開的,截至 2015 年 4 月 30 日,共有 189,315 筆臨床試驗資料於 該資料庫註冊,為現今醫學或公共衛生等領域提供了一個良好的研究平台。 本研究嘗試於 臨床試驗註冊庫中篩選出 2012 年至 2013 年度與 抗藥物有關的臨床試驗,進行一整體性及最新之現特性趨勢研究,分析各臨床 試驗因素特點及其相互關係,探討現時抗抑鬱藥物臨床試驗最新之發展趨勢及 特點,以便予有關研究人員作一回顧性之參考。 結果 抗抑鬱藥物臨床試驗以針對重度抑鬱症(Major Depressive Disorder)佔最大 比例,達 53.72%,受試者性別組合以不區分男女(Both)佔 91.15%,試驗規模一 般較小,受試者人數在 0-100 人之臨床試驗佔 67.71%,研究目的以治療佔 66.71%,統計分析方面,與研究經費(Funded By)有顯著相關性(P<0.05)的變量 有疾病狀況(Conditions Count)、年齡組別(Age Group)、試驗階段(Phase)、受試 者人數(Enrollment)及主要研究目的(Primary Purpose);而與臨床試驗階段(Phase) 相關顯著性相關的變量有性別(Gender)、年齡組別(Age Group)、受試者人數 (Enrollment) 、 臨 床 試 驗 終 點 分 類 (Endpoint Classification) 、 主 要 研 究 目 的 (Primary Purpose)、盲法(Masking)、研究經費(Funded By)。 總結 歸納及分析 2012-2013 於 臨床試驗註冊庫有關抑鬱症之 192 筆臨床試驗,本研究較全面地分析各臨床試驗因素及變量特點,探討不同 經費來源、不同臨床試驗階段之試驗設計特點,並對臨床試驗註冊庫試驗資料 之公佈提出了建議,望能對各醫療及相關機構作一全面及較高品質證據(High quality evidence)的決策依據。 關鍵字: 抗抑鬱藥;;抑鬱症

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Institute of Chinese Medical Sciences






Depression, Mental -- Treatment

抑鬱症 -- 治療



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