A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Generic Escitalopram; Innovator Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): 10mg/d or 20mg/d; 10mg/d or 20mg/d
Other intervention name(s): Generic Escitalopram Oxalate Tablet; Lexapro®
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: 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