depression
Conditions
Interventions
(white race + liver-qi stagnation + acupuncture) group:acupuncture
(yellow race + liver-qi stagnation + integration) group:acupuncture+rTMS
(white race + liver-qi stagnation +rTMS) group:rTMS
(yellow race + liver-qi stagnation +rTMS) group:rTMS
(yellow race + heart-spleen deficiency + rTMS) group:rTMS
(white race + liver-qi stagnation + integration) group:acupuncture+rTMS
(white race + heart-spleen deficiency + rTMS) group:rTMS
(white race + heart-spleen deficiency + acupuncture) group:acupuncture
(yellow race + heart-spleen deficiency + integration) group:acupuncture+rTMS
(white race + heart-spleen deficiency + integration) group:acupuncture+rTMS
(yellow race + heart-spleen deficiency + acupuncture):acupuncture
(yellow race + liver-qi stagnation + acupuncture) group:acupuncture
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–80 years; (2) Meet the diagnostic criteria for a depressive disorder episode in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5); (3) Meet the diagnostic criteria for Yu Bing (Depressive Disorder) in the Standards for the Diagnosis and Therapeutic Efficacy of Traditional Chinese Medicine Diseases and Syndromes including the criteria for Liver Qi Stagnation Syndrome and Spleen-Heart Deficiency Syndrome; (4) Have mild to moderate depression with a score >8 and <35 on the Hamilton Depression Rating Scale (HAMD) and =14 on the Hamilton Anxiety Rating Scale (HAMA); (5) Have stable vital signs clear consciousness and the ability to cooperate with physical examinations and questionnaire surveys; (6) Be experiencing their first episode of illness or have not used antidepressants mood stabilizers or antipsychotics within 2 weeks prior to the start of the treatment; (7) Understand the procedures and content of the trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with any psychiatric disorder other than depressive disorder (e.g. schizophrenia spectrum and related disorders bipolar and related disorders obsessive-compulsive and related disorders); (2) History of attempted suicide current high risk of suicide or a score =3 on Item 3 (suicidal ideation) of the Hamilton Depression Rating Scale (HAMD) or assessed by a specialist physician as having suicidal tendencies or behaviors; (3) Depressive episode secondary to a somatic or neurological disease such as depression caused by hypothyroidism; (4) Presence of severe or unstable cardiovascular respiratory hepatic renal endocrine hematological (e.g. bleeding tendency) or other systemic diseases; (5) History of alcohol or drug dependence within the past year prior to screening; (6) Inability to swallow oral medications or history of gastrointestinal surgery that may interfere with the absorption distribution metabolism or excretion of medications; (7) Systematic use of antidepressants within 2 weeks prior to screening or discontinuation of psychotropic medications less than 7 half-lives before randomization (at least 2 weeks for monoamine oxidase inhibitors at least 1 month for fluoxetine); (8) Received systemic modified electroconvulsive therapy (MECT) or vagus nerve stimulation (VNS) within 3 months prior to screening or systemic psychotherapy; received systemic light therapy laser therapy acupuncture related to psychiatry systemic biofeedback therapy or other physical treatments related to psychiatric disorders within 2 weeks prior to screening; undergone psychiatric surgery; (9) Participated in other drug clinical trials within 3 months prior to screening; (10) Presence of severe somatic diseases malignant tumors or hematological disorders; (11) Presence of metallic foreign bodies in the skull metallic dental prostheses in the mouth cardiac pacemaker cochlear implants increased intracranial pressure or epilepsy; (12) Pregnant or breastfeeding women; (13) Other reasons that prevent the participant from receiving or completing the treatment as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI;PSQI;TCMSSS;response rate; | — |
Countries
China
Contacts
Public ContactDongdongYang
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed