depressive disorder
Conditions
Interventions
Experimental group:Shuyu powder and paroxetine hydrochloride tablets were taken orally
TCM control group:Shuyu powder and paroxetine hydrochloride simulated tablets were taken orally
The western medicine control group:paroxetine hydrochloride tablets and Chinese medicine free decoction granule placebo
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) meet the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) Major Depressive disorder (MDD) Disorder), referring to "depression" and "anxiety disorder" in "TCM Treatment of Mental and Behavioral DiseasesInterpretation of will and Mind Syndrome Differentiation" (2008) and "depression disease" in "TCM Diagnostic Efficacy Criteria of Diseases and Syndromes" (2012), formulated the TCM diagnostic criteria of "insufficient spirit, depression of mind and soul". (2) The total score of the first 17 items of the 24 items of the Hamilton Depression Scale (HAMD) was =8 and =24; (3) age 12-18 years old, both sexes; (4) patients who were willing to be tested and signed informed consent; (5) had not taken antidepressant or anti-anxiety drugs in the past, or had taken but stopped the drugs for more than 1 month, beyond the drug washout period;
Exclusion criteria
Exclusion criteria: (1) patients with severe heart, liver or kidney dysfunction or complicated with other serious underlying diseases; (2) female patients during pregnancy or lactation; (3) patients with bipolar disorder and other psychotic disorders; (4) patients with previous allergies to the drugs used in the trial; (5) patients with long-term use of other psychotropic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale, HAMD-24; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine examination;Nurses' Global Assessment of Suicide Risk scale;Non-Suicidal Self-Injury questionnaire;TCM syndrome quantitative table score;Somatic Selfrating Scale;liver function test; | — |
Countries
China
Contacts
Public ContactZhaojun Yan
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed