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

NCT ID: NCT01467804

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

JWXYJN plus placebo of Sertraline

Intervention Type DRUG

JWXYJN 3.6g/d plus placebo of sertraline

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

Group Type ACTIVE_COMPARATOR

Sertraline plus placebo of JWXYJN

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

JWXYJN plus placebo of Sertraline

JWXYJN 3.6g/d plus placebo of sertraline

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Su Rui

OTHER

Sponsor Role lead

Responsible Party

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Su Rui

assistant researcher

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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China Academy of Chinese Medicine Science

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Su Rui, PHD

Role: CONTACT

[email protected]
86-10-13260397833

Facility Contacts

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Su Rui, PHD

Role: primary

[email protected]
86-10-13260397833

Other Identifiers

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y00741015-zjx

Identifier Type: -

Identifier Source: org_study_id