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Sponsors and Collaborators: |
Shanghai Mental Health Center Jiangsu Nhwa Pharmaceutical Co.,LTD |
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Information provided by: | Shanghai Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00866593 |
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 |
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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 |
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 |
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1: Experimental
Generic Escitalopram Oxalate Tablets
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Drug: Generic Escitalopram
10mg/d or 20mg/d
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2: Active Comparator
Innovator Escitalopram(Lexapro®)
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Drug: Innovator Escitalopram
10mg/d or 20mg/d
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Huafang LI, MD,PhD | Drug Clinical Trial Office, Shanghai Mental Health Center |
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 |
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 |
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 |
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 |