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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2013
• Main ID: NCT00866593
• Date of registration: 18/03/2009
• Primary sponsor: Shanghai Mental Health Center
• Public title: A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
• Scientific 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
• Date of first enrolment: March 2009
• Target sample size: 260
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00866593
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Huafang LI, MD,PhD
• Affiliation: Drug Clinical Trial Office, Shanghai Mental Health Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Generic Escitalopram

Drug: Innovator Escitalopram

Primary Outcome(s)

the change of HAMD-17 total score [Time Frame: from the baseline to week 8]

Secondary Outcome(s)

the change of HAMA total score [Time Frame: from the baseline to week 8]

the change of MADRS total score [Time Frame: from the baseline to week 8]

the change of Sheehan Disability Scale(SDS) [Time Frame: from the baseline to Week 8]

the change of VAS-PI [Time Frame: from the baseline to Week 8]

the clinical global impression (CGI),including CGI-I and CGI-S [Time Frame: from the baseline to week 8]

Secondary ID(s)

2004L04118

SMHC-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jiangsu Nhwa Pharmaceutical Co.,LTD