計劃書編號EFC6224
2007-02-25 - 2008-06-30
Phase III
終止收納5
ICD-10F33.2
鬱症，復發，重度無精神病特徵
ICD-9296.33
重鬱症，復發，重度未提及精神病行為
一項多國、多中心、雙盲、含安慰劑對照組及平行組別之試驗，重鬱症之成人患者，除了每日投與 escitalopram 10毫克外，再加上每日兩次SR58611A 350毫克，與安慰劑相較，其在固定劑量下之療效與安全性
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試驗申請者
賽諾菲股份有限公司
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試驗委託 / 贊助單位名稱
賽諾菲股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 停止召募
實際收案人數
0 停止召募
實際收案人數
0 停止召募
實際收案人數
0 停止召募
適應症
Major depression disorder
試驗目的
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
藥品名稱
SR58611A
主成份
SR58611A
劑型
tablet
劑量
350
評估指標
無法取得
主要納入條件
Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30
Exclusion Criteria:
Patient is at immediate risk for suicidal behavior
Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Patients with a current depressive episode secondary to a general medical disorder
Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
Patients with severe or unstable concomitant medical conditions
Pregnant, breastfeeding, or likely to become pregnant during the study
Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
The investigator will evaluate whether there are other reasons why a patient may not participate.
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30
Exclusion Criteria:
Patient is at immediate risk for suicidal behavior
Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Patients with a current depressive episode secondary to a general medical disorder
Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
Patients with severe or unstable concomitant medical conditions
Pregnant, breastfeeding, or likely to become pregnant during the study
Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
The investigator will evaluate whether there are other reasons why a patient may not participate.
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
500 人
