Active and passive intervention conbined with characteristic treatment regimens of traditional Chinese medicine in subliminal depression: a multicentre, randomized controlled study
- Conditions
- Subthreshold depression
- Registration Number
- ITMCTR2000003218
- Lead Sponsor
- Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnostic criteria of depression under the threshold of Western medicine;
Diagnosis standard of subthreshold depression: it has symptoms of depression, but fails to meet the symptom indicators required for diagnosis of depression (more than 5 of 9 items: loss of interest, no pleasure; energy loss or fatigue; psychomotor retardation or agitation; low self-evaluation, self blame, or guilt; difficulty in association or reduction of conscious thinking ability; recurrent thoughts of dying or having self Killing and self injuring behaviors; sleep disorders, such as insomnia, early wake-up, or excessive sleep; loss of appetite or weight; hyposexual desire) or course indicators (duration greater than 2 weeks).
2. The patients with CES-D score >= 16;
3. Hamilton Depression Scale (HAMD-17) score: 7 points <= HAMD total score < 17 points;
4. The patients with qi stagnation as the main constitution were classified and judged by the constitution of traditional Chinese medicine;
5. Patients aged over 18 and under 65, regardless of gender;
6. Patients who can independently complete the questionnaire, use the app, have informed consent and voluntarily fill in the questionnaire;
Only those who meet the above six criteria can be selected into the research group.
1. Patients with clinically confirmed depression, previous mental illness or organic mental disorder;
2. Patients with serious liver and kidney function damage, serious heart rate disorder or cardiac insufficiency;
3. Pregnancy, lactation and objects with pregnancy plan;
4. Patients with depressive episode caused by psychoactive substance and non addictive substance;
5. Patients who used other drugs or therapies to treat depression at the same time during the trial;
6. Known targets of drinking or substance dependence;
7. Patients with strong suicide attempt or behavior;
8. Patients who are participating in other clinical trials;
9. Those who fail to treat according to the specified requirements, fail to judge the curative effect or incomplete data that affect the judgment of curative effect or safety;
10. Patients who had received antidepressant treatment within one week before the trial.
Those with one of the above items will not be included in the test.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CES-D;
- Secondary Outcome Measures
Name Time Method HAMD;Constitution scale score;PHQ-9;