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A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
This study is currently recruiting participants.
Verified by Shanghai Mental Health Center, March 2009
First Received: March 18, 2009   Last Updated: March 19, 2009   History of Changes
Sponsors and Collaborators: Shanghai Mental Health Center
Jiangsu Nhwa Pharmaceutical Co.,LTD
Information provided by: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT00866593
  Purpose

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 Intervention Phase
Depression
Drug: Generic Escitalopram
Drug: Innovator Escitalopram
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • the change of HAMD-17 total score [ Time Frame: from the baseline to week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change of MADRS total score [ Time Frame: from the baseline to week 8 ] [ Designated as safety issue: No ]
  • the change of HAMA total score [ Time Frame: from the baseline to week 8 ] [ Designated as safety issue: No ]
  • the clinical global impression (CGI),including CGI-I and CGI-S [ Time Frame: from the baseline to week 8 ] [ Designated as safety issue: No ]
  • the change of VAS-PI [ Time Frame: from the baseline to Week 8 ] [ Designated as safety issue: No ]
  • the change of Sheehan Disability Scale(SDS) [ Time Frame: from the baseline to Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Generic Escitalopram Oxalate Tablets
Drug: Generic Escitalopram
10mg/d or 20mg/d
2: Active Comparator
Innovator Escitalopram(Lexapro®)
Drug: Innovator Escitalopram
10mg/d or 20mg/d

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866593

Contacts
Contact: Huafang LI, MD,PhD 86-21-64387250 ext 3128 lhlh5@yahoo.com.cn
Contact: Yan LI, MD 86-21-64387250 ext 3122 liyan7721@yeah.net

Locations
China
Shanghai Mental Health Center Recruiting
Shanghai, China, 200030
Contact: Huafang LI, MD,PhD     86-21-64387250 ext 3128     lhlh5@yahoo.com.cn    
Contact: Yan LI, MD     86-21-64387250 ext 3122     liyan7721@yeah.net    
Principal Investigator: Huafang LI, MD,PhP            
Sub-Investigator: Yan LI, MD            
China, Hebei
Hebei Mental Health Center Recruiting
Baoding, Hebei, China, 071000
Contact: Bo DU, MD     0312-5976202     db670196@sina.com    
Principal Investigator: Bo DU, MD            
China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Shiping XIE, MD     025-83700011 ext 6365     xieshiping@medmail.com.cn    
Principal Investigator: Shiping XIE, MD            
China, Shaanxi
the First Affiliated Hospital,Medical School of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Chengge GAO, MD     029-85323472     yaogaow@163.com    
Principal Investigator: Chengge GAO, MD            
Xi'an Mental Health Center Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Feihu LIU, MD     029-85551336     feihu1978@163.com    
Principal Investigator: Feihu LIU, MD            
China, Yunnan
The First Affilliated Hospital Of Kunming Medical College Recruiting
Kunming, Yunnan, China, 650032
Contact: Xiufeng XU, MD     13888261558     xfxu2004@sina.com    
Principal Investigator: Xiufeng XU, MD            
Sponsors and Collaborators
Shanghai Mental Health Center
Jiangsu Nhwa Pharmaceutical Co.,LTD
Investigators
Principal Investigator: Huafang LI, MD,PhD Drug Clinical Trial Office, Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Shanghai Mental Health Center ( LI, Huafang )
Study ID Numbers: 2004L04118, SMHC-101
Study First Received: March 18, 2009
Last Updated: March 19, 2009
ClinicalTrials.gov Identifier: NCT00866593     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Shanghai Mental Health Center:
major depressive disorder(MDD)
depression
antidepressant
escitalpram oxalate
generic
innovator
Lexapro
efficacy
safety
multicenter
double-blind
randomized
chinese
HAMD
MADRS
HAMA
VAS-PI
SDS
CGI

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Cholinergic Antagonists
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Cholinergic Agents
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Behavioral Symptoms
Muscarinic Antagonists
Mental Disorders
Mood Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Depression
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2009