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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: Sertraline plus placebo of JWXYJN
* Drug: JWXYJN plus placebo of Sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older. A diagnosis of MDD, single episode or recurrent, according to DSM-IV Meets DSM-IV criteria for Major Depressive Disorder. factor score from the 24-item Hamilton Depression Rating Scale (HAM-D) >20,<35 Patients must be able to provide written informed consent Exclusion Criteria: Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder. Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes). Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit. Patients who meet criteria for any of the following DSM-IV MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern [d] with Psychotic Features. Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese medicine<br>There are 90 patients with mild to moderate depress in JWXY group, who take the JWXY capsule, and placebo of Sertraline, for 2 months | Drug: JWXYJN plus placebo of Sertraline<br>* JWXYJN 3.6g/d plus placebo of sertraline<br>|
| Active Comparator: westen medicine<br>There are 90 patients with mild to moderate depress in westen medicine group, who take Sertraline, and placebo of the JWXY capsule, for 2 months | Drug: Sertraline plus placebo of JWXYJN<br>* oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD scale | HAMD scale to access the depression level | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy,, safety,, JWXYJN