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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by China Academy of Chinese Medical Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Su Rui, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01467804
First received: November 7, 2011
Last updated: November 9, 2011
Last verified: January 2010
  Purpose

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.


Condition Intervention
Depressive Disorder
Drug: Sertraline plus placebo of JWXYJN
Drug: JWXYJN plus placebo of Sertraline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • HAMD scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HAMD scale to access the depression level


Estimated Enrollment: 180
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467804

Contacts
Contact: Su Rui, PHD 86-10-13260397833 surui20032000@yahoo.com.cn

Locations
China, Beijing
China Academy of Chinese Medicine Science Not yet recruiting
Beijing, Beijing, China, 100700
Contact: Su Rui, PHD    86-10-13260397833    surui20032000@yahoo.com.cn   
Sponsors and Collaborators
Su Rui
  More Information

No publications provided

Responsible Party: Su Rui, assistant researcher, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01467804     History of Changes
Other Study ID Numbers: y00741015-zjx
Study First Received: November 7, 2011
Last Updated: November 9, 2011
Health Authority: China:Academy of Traditional Chinese Medical sciences

Keywords provided by China Academy of Chinese Medical Sciences:
efficacy,
safety,
JWXYJN

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014