Bipolar disorder
Conditions
Interventions
Experimental Group:Tongyang Xingshen Decoction includes Bupleurum 10g, Oyster shell 30g (boil first), Pearl mother 30g (boil first), Gardenia 10g, Citrus aurantium 10g, Magnolia officinalis 10g, Alpin
Control Group:The control group received a Chinese herbal placebo identical in appearance to that of the experimental group, combined with quetiapine treatment within the same dosage range.
Sponsors
Guangzhou Medical University Affiliated Brain Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Age between 18-65 years old, Han ethnicity; 2) Meets the diagnostic criteria for bipolar II disorder according to DSM-5, currently in an acute depressive episode, with HAMD score =17 and YMRS score <6; 3) Received quetiapine monotherapy during the run-in period and signed the informed consent form; 4) Chinese medicine diagnosis: liver qi stagnation and spleen deficiency syndrome.
Exclusion criteria
Exclusion criteria: 1)Meets any other diagnostic criteria specified in DSM-5; 2) High suicide risk: Currently has suicidal thoughts or a suicide plan, or scores 3 or 4 on the suicide item of the HAMD-17 scale, or is judged by the investigator to be at high suicide risk; 3) Hypothyroidism, or major somatic diseases such as heart, liver, or kidney conditions; 4) Neurological diseases such as central nervous system infections, stroke, hydrocephalus, or brain tumors; 5) Received electroconvulsive therapy (ECT) or experimental drugs within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD) Reduction Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale;Yang Mania Scale;Cognitive Function Battery Consensus Version / MATRICS; | — |
Countries
China
Contacts
Public ContactNing Yuping
Guangzhou Medical University Affiliated Brain Hospital
Outcome results
None listed