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
Recruitment status was Not yet recruiting
Sponsor:
Su Rui
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
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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
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 Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms 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 May 19, 2013