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

This study has been completed.
Sponsor:
Collaborator:
Jiangsu Nhwa Pharmaceutical Co.,LTD
Information provided by (Responsible Party):
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT00866593
First received: March 18, 2009
Last updated: April 1, 2013
Last verified: April 2013
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ]

Enrollment: 260
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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
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, see Learn About Clinical Studies.

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

Locations
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
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
ClinicalTrials.gov Identifier: NCT00866593     History of Changes
Other Study ID Numbers: 2004L04118, SMHC-101
Study First Received: March 18, 2009
Last Updated: April 1, 2013
Health Authority: China: 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

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

ClinicalTrials.gov processed this record on July 22, 2014