Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
Jiangsu Nhwa Pharmaceutical Co., Ltd.
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of Generic Escitalopram in the treatment of Chinese patients with depression compared with Innovator Escitalopram(Lexapro®) b...
Detailed Description
This is a double-blind, parallel assignment, randomized and innovator controlled study. The subjects investigated are outpatients with major depressive disorder(MDD)according to DSM-IV from the Chines...
Eligibility Criteria
Inclusion
- Outpatients
- Patients who met DSM-IV criteria for major depressive disorder(MDD):a single major depressive episode or recurrent major depressive episode, without psychotic features, MDD is primary mental disorder
- Age from 18-65 years old, male or female
- HAMD-17 total score at least 20 at screening and baseline, and first item's score at least 2
- CGI-S at least 4 at screening and baseline
- Written informed consent provided by patient himself/herself
Exclusion
- Severe suicide attempt
- Any unstable medical illness would affect study or increase patients' risk to participate this study, including disease of heart, lung, liver, kidney,cardiovascular system, eyes, nervous system, endocrine system, hematological system etc.
- History of epilepsy(except children febrile seizure/convulsion)
- Known history of high intraocular pressure or angle closure glaucoma
- Psychoactive substance abuse or dependence within 1 year prior enrollment
- Depressive episode due to other mental disorders or physical diseases
- Bipolar disorder, rapid cycling/circulation
- Female patients during their pregnant and lactation period or childbearing potential during study
- History of severe drug hypersensitivity
- A significantly clinical abnormal value in ECG or lab results which would affect assessment for efficacy or safety decided by the investigator
- ALT and AST values in the liver function test exceeding two times of the upper limits of normal values
- Participation in another drug trial within 28 days prior enrollment into this study
- Use of MAOI within 4 weeks prior to randomization
- Duration of discontinuing other psychotropics is shorter than its 7 half life periods
- Patients can not administrate drug according to medical order
- HAMD total score decreased more than 25% from screening to baseline
- Use of Electroconvulsive therapy within half year prior enrollment
- Known lack of efficacy to escitalpram by formal treatment before
- Other situation unsuitable to enroll in this study as judged by the investigator
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00866593
Start Date
March 1 2009
End Date
March 1 2010
Last Update
April 4 2013
Active Locations (6)
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1
Hebei Mental Health Center
Baoding, Hebei, China, 071000
2
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
3
the First Affiliated Hospital，Medical School of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
4
Xi'an Mental Health Center
Xi'an, Shaanxi, China, 710061