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

NCT01467804 | Unknown DMC

• 1 other identifier: y00741015-zjx
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

efficacy,; safety,; JWXYJN

Outcome Measures

Primary Outcomes (1)

• HAMD scale

  HAMD scale to access the depression level

  12 weeks

Study Arms (2)

Chinese medicine

EXPERIMENTAL

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

westen medicine

ACTIVE COMPARATOR

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

Interventions

Sertraline plus placebo of JWXYJN DRUG

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

westen medicine

JWXYJN plus placebo of Sertraline DRUG

JWXYJN 3.6g/d plus placebo of sertraline

Chinese medicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Su Rui: lead

Study Sites (1)

China Academy of Chinese Medicine Science

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Su Rui, PHD

CONTACT

86-10-13260397833; surui20032000@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant researcher

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 10, 2011

Record last verified: 2010-01

Locations

CN (1)