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

Primary Purpose

Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sertraline plus placebo of JWXYJN

JWXYJN plus placebo of Sertraline

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring efficacy,, safety,, JWXYJN

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

China Academy of Chinese Medicine Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chinese medicine

westen medicine

Arm Description

There are 90 patients with mild to moderate depress in JWXY group, who take the JWXY capsule, and placebo of Sertraline, for 2 months

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

Outcomes

Primary Outcome Measures

HAMD scale

HAMD scale to access the depression level

Secondary Outcome Measures

Full Information

NCT ID

NCT01467804

First Posted

November 7, 2011

Last Updated

November 9, 2011

Sponsor

Su Rui

1. Study Identification

Unique Protocol Identification Number

NCT01467804

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Su Rui

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

efficacy,, safety,, JWXYJN

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chinese medicine

Arm Type

Experimental

Arm Description

There are 90 patients with mild to moderate depress in JWXY group, who take the JWXY capsule, and placebo of Sertraline, for 2 months

Arm Title

westen medicine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sertraline plus placebo of JWXYJN

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

JWXYJN plus placebo of Sertraline

Intervention Description

JWXYJN 3.6g/d plus placebo of sertraline

Primary Outcome Measure Information:

Title

HAMD scale

Description

HAMD scale to access the depression level

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Su Rui, PHD

Phone

86-10-13260397833

surui20032000@yahoo.com.cn

Facility Information:

Facility Name

China Academy of Chinese Medicine Science

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100700

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Su Rui, PHD

Phone

86-10-13260397833

surui20032000@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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