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Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder

NCT01467804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2011-11-10

No results posted yet for this study

Summary

This is a randomized, double-blind multi centric clinic study. Both of therapist and patient are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for major depressive disorder, the score of HAMD-item\>20，\<35；and meet the criteria for TCM syndrome of "Liver Qi stagnation and Transformation of Stagnant Qi into Fire". Patients are randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50 mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at baseline and end of program. Then data will be analyzed with SPSS software to determine the efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate major depressive disorder.

Conditions

  • Depressive Disorder

Interventions

DRUG

Sertraline plus placebo of JWXYJN

oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN

DRUG

JWXYJN plus placebo of Sertraline

JWXYJN 3.6g/d plus placebo of sertraline

Sponsors & Collaborators

  • Su Rui

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467804 on ClinicalTrials.gov