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A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866593
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : April 4, 2013
Jiangsu Nhwa Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shanghai Mental Health Center

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®) by evaluating the change of HAMD-17 total score from the baseline to week 8.

Condition or disease Intervention/treatment Phase
Depression Drug: Generic Escitalopram Drug: Innovator Escitalopram Phase 2 Phase 3

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 Chinese population. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The fixed dose(generic escitalopram 10mg/d or Innovator Escitalopram(Lexapro®) 10mg/d) duration is 2 week. After the first 2 weeks, according to CGI and investigator's assessment the patients are administrated 2 different dose, one is previous dose 10mg/d, the other is high dose 20mg/d. In this study, total duration lasts for 8 weeks.

The efficacy and safety of Innovator Escitalopram(Lexapro®) in the treatment of patients with MDD have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of genetic escitalopram in the treatment of Chinese patients with MDD. Therefore, the double blind and innovator control(Lexapro®) design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with MDD are tolerant to the drug in practical clinical treatment.

The purpose of MDD patient treatment is to improve the core symptoms, prevent suicide, alleviate the side reactions caused by the antidepressant, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 8 weeks.

The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antidepressants and in the treatment of patients with MDD. The high inter-investigator reliability and repeated measurement reliability of these scales(HAMD,MADRS,HAMA) have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The VAS-PI(Visual Analog Scale-Pain Intensity) is used to evaluate the reduction in pain intensity,a common symptom of patients with MDD. It has good reliability and validity. The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social and family life.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Generic Escitalopram Oxalate Tablets
Drug: Generic Escitalopram
10mg/d or 20mg/d
Other Name: Generic Escitalopram Oxalate Tablet

Active Comparator: 2
Innovator Escitalopram(Lexapro®)
Drug: Innovator Escitalopram
10mg/d or 20mg/d
Other Name: Lexapro®

Primary Outcome Measures :
  1. the change of HAMD-17 total score [ Time Frame: from the baseline to week 8 ]

Secondary Outcome Measures :
  1. the change of MADRS total score [ Time Frame: from the baseline to week 8 ]
  2. the change of HAMA total score [ Time Frame: from the baseline to week 8 ]
  3. the clinical global impression (CGI),including CGI-I and CGI-S [ Time Frame: from the baseline to week 8 ]
  4. the change of VAS-PI [ Time Frame: from the baseline to Week 8 ]
  5. the change of Sheehan Disability Scale(SDS) [ Time Frame: from the baseline to Week 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866593

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China, Hebei
Hebei Mental Health Center
Baoding, Hebei, China, 071000
China, Jiangsu
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
China, Shaanxi
the First Affiliated Hospital,Medical School of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Xi'an Mental Health Center
Xi'an, Shaanxi, China, 710061
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
China, Yunnan
The First Affilliated Hospital Of Kunming Medical College
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
Shanghai Mental Health Center
Jiangsu Nhwa Pharmaceutical Co., Ltd.
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Principal Investigator: Huafang LI, MD,PhD Drug Clinical Trial Office, Shanghai Mental Health Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shanghai Mental Health Center Identifier: NCT00866593    
Other Study ID Numbers: 2004L04118
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by Shanghai Mental Health Center:
major depressive disorder(MDD)
escitalpram oxalate
Additional relevant MeSH terms:
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Muscarinic Antagonists
Cholinergic Antagonists
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agents