depression
Conditions
Interventions
Study group:Escitalopram and Gui-Fu-Di-Huang pills combination in the treatment
Sponsors
Beijing Anding Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Han nationality, Outpatients or inpatients between the ages of 18 and 60, of either sex. 2.Patients who meet the diagnostic criteria for DSM-5 depression, either first or recurrent, without psychotic symptoms, as determined by the Chinese version of the MINI International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 stereotype interview. 3.Screening and baseline period Hamilton Depression Scale-17 (HAMD-17) score: 17 points = HAMD-17 score = 23 points. 4.According to the " Classification and Judgment Criteria for constitution of Traditional Chinese Medicine", patients meeting the criteria of pure Yang deficiency constitution (the transformation score of yang-deficiency constitution= 40 points, the transformation scores of other biased constitutions < 30 points) or yang-deficiency constitution is the primary constitution with the highest transformation score, the transformation scores of other constitutions < 40 points. 5.Patients who are tendency to deficiency of kidney yang (having one of the symptoms of lumbar and knee soreness and coldness or poor urination or clear and long urine). 6.Patients living in Beijing within the last 2 years. 7.Patients who have an elementary school education or higher and are able to understand the content of the scale. 8.Patients understanding and willing to participate the study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients having more than 2 kinds of mixed constitution (the transformation scores of biased constitutions=40). 2.Patients having special concurrent body constitution: Yang deficiency -Yin deficiency constitution or Phlegm-dampness constitution (the transformation scores of Yang deficiency and Yin deficiency constitution or Phlegm-dampness constitution= 40). 3.Patients with severe or unstable cardiac, hepatic, renal, endocrine, hematological or other somatic diseases or a history of epilepsy. 4.Patients with a history of suicide attempts or currently high risk of suicide (suicidality = 17 points assessed by M.I.N.I stereotype interview) or HAMD-17 scale item 3 (suicide score) = 3 points. 5.Patients with depressive episodes secondary to other psychiatric or somatic disorders and having psychotic symptoms. 6.Patients with alcohol or drug dependence. 7.Patients whose physical examination or laboratory tests are found to be abnormal by the investigator during the screening or baseline period and are judged to be clinically significant. 8.Patients whose electrocardiograms are found to be abnormal by the investigator during screening period with significant clinical significance, such as male QTc interval = 450ms, female QTc interval = 470ms. 9.Patients who take antidepressant medication regularly within 2 weeks prior to screening and not having discontinued antidepressant medication for 7 half-lives prior to randomization to the group. 10.Patients who have applied glucocorticoids, antibiotics, microecological regulators, gastrointestinal motility drugs within 1 month. 11.Patients who have a previous history of hypersensitivity to escitalopram or known possible hypersensitivity to the ingredients of Gui-Fu-Di-Huang pills. 12.Patients who are breastfeeding, pregnant, or planning to become pregnant within 3 months of the end of the study. 13.Patients who have participated in clinical studies with other drugs within 1 month prior to screening. 14.Patients who cannot take medication as prescribed by the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14, FS-14; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD-17;Clinical Global Impressions scale, CGI;Brief 16-item quick inventory of depressive symptomatology self-report, QIDS-SR16;The constitution in Chinese medicine questionnaire;Snaith-Hamilton Pleasure Scale, SHAPS; | — |
Countries
China
Contacts
Public ContactLing Zhang
Beijing Anding Hospital affiliated to Capital Medical University
Outcome results
None listed