Depressive DisorderNCT01467804
Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder
A study of Depressive Disorder, run by Su Rui at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
China Academy of Chinese Medicine Science
Beijing, Beijing Municipality, 100700
Su Rui, PHD, 86-10-13260397833, surui20032000@yahoo.com.cn
About 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.
- Conditions
- Depressive Disorder
- Being tested
- Sertraline plus placebo of JWXYJN, JWXYJN plus placebo of Sertraline
- Keywords
- efficacy,, safety,, JWXYJN
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline plus placebo of JWXYJNDrug
oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN
JWXYJN plus placebo of SertralineDrug
JWXYJN 3.6g/d plus placebo of sertraline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sertraline plus placebo of JWXYJN |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD scale
HAMD scale to access the depression level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Su Rui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Su Rui, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467804
- Sponsor's protocol ID
- y00741015-zjx
- Status last verified
- Jan 2010
- First submitted
- 7 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01467804
- Acronym / sponsor ID
- y00741015-zjx
- Conditions
- Depressive Disorder
- Keywords
- efficacy,, safety,, JWXYJN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Su RuiUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese medicine | Experimental | Drug: JWXYJN plus placebo of SertralineThere are 90 patients with mild to moderate depress in JWXY group, who take the JWXY capsule, and placebo of Sertraline, for 2 months |
| westen medicine | Active comparator | Drug: Sertraline plus placebo of JWXYJNThere are 90 patients with mild to moderate depress in westen medicine group, who take Sertraline, and placebo of the JWXY capsule, for 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | westen medicine |
| JWXYJN plus placebo of SertralineJWXYJN 3.6g/d plus placebo of sertraline | Drug | Chinese medicine |
Primary outcome
HAMD scale
Time frame: 12 weeks
HAMD scale to access the depression level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depressive Disorder, run by Su Rui at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Rui, PHD (86-10-13260397833, surui20032000@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011; AzTrials last refreshed its copy on 28 Oct 2026.