A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
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
2 other identifiers
interventional
260
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 depression
Started Mar 2009
Shorter than P25 for phase_2 depression
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedApril 4, 2013
April 1, 2013
1 year
March 18, 2009
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the change of HAMD-17 total score
from the baseline to week 8
Secondary Outcomes (5)
the change of MADRS total score
from the baseline to week 8
the change of HAMA total score
from the baseline to week 8
the clinical global impression (CGI),including CGI-I and CGI-S
from the baseline to week 8
the change of VAS-PI
from the baseline to Week 8
the change of Sheehan Disability Scale(SDS)
from the baseline to Week 8
Study Arms (2)
1
EXPERIMENTALGeneric Escitalopram Oxalate Tablets
2
ACTIVE COMPARATORInnovator Escitalopram(Lexapro®)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hebei Mental Health Center
Baoding, Hebei, 071000, China
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029, China
the First Affiliated Hospital，Medical School of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Xi'an Mental Health Center
Xi'an, Shaanxi, 710061, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
The First Affilliated Hospital Of Kunming Medical College
Kunming, Yunnan, 650032, China
Related Publications (1)
Yu Y, Li H, Wang B, Li K, Xu X, Shi J, Gao C, Tan Q. Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial. Shanghai Arch Psychiatry. 2013 Apr;25(2):107-15. doi: 10.3969/j.issn.1002-0829.2013.02.007.
PMID: 24991142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huafang LI, MD,PhD
Drug Clinical Trial Office, Shanghai Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 20, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
April 4, 2013
Record last verified: 2013-04