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

Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sertraline plus placebo of JWXYJNoral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN

Drug:JWXYJN plus placebo of SertralineJWXYJN 3.6g/d plus placebo of sertraline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: November 2011

Completed Date: December 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: HAMD scale

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Su Rui

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01467804

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