Depressive Disorder
Conditions
Keywords
efficacy,, safety,, JWXYJN
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.
Interventions
DRUGSertraline plus placebo of JWXYJN
oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN
DRUGJWXYJN plus placebo of Sertraline
JWXYJN 3.6g/d plus placebo of sertraline
Sponsors
Su Rui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD scale | 12 weeks | HAMD scale to access the depression level |
Countries
China
Contacts
Primary ContactSu Rui, PHD
Outcome results
None listed