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

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.

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: JWXYJN plus placebo of Sertraline; Drug: Sertraline plus placebo of JWXYJN

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • China Academy of Chinese Medicine Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese medicine; 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; JWXYJN 3.6g/d plus placebo of sertraline
Active Comparator: westen medicine; 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; oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Su Rui

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 10, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: safety,; efficacy,; JWXYJN
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: y00741015-zjx