Bipolar Disorder Depressive Episode
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patient Group (BD-DMX/BD-DNMX): 1. Meet the DSM-5 criteria for bipolar disorder depressive episodes; 2. BD-DMX Group: depressive episodes with >=3 manic symptoms (CUDOS-M-S score >=8); 3. BD-DNMX Group: depressive episodes with =17, age 15-55 years. Healthy Control Group: 1. Age and gender matched with the patient group; 2. No history of psychiatric disorders or family history of mental illness.
Exclusion criteria
Exclusion criteria: All participants: 1. Currently predominantly experiencing manic episodes; 2. Comorbid schizophrenia, organic brain disease, or substance dependence; 3. Severe physical illnesses (such as liver or kidney dysfunction, tumors); 4. Pregnant or breastfeeding women. Additional exclusions for the case group: 1. Patients in longitudinal treatment studies who have not used medications outside the study protocol at enrollment; 2. Unable to comply with follow-up or assessment scales.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Manic/Mixed Symptoms;Treatment remission rate: HAMD-17 score decrease >=50% (week 8);Symptom fluctuation: YMRS score decrease>=50%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of Depressive Symptoms;Levels of Endocrine Blood Biomarkers;Levels of Inflammatory Blood Biomarkers;Levels of Metabolic Blood Biomarkers;Levels of Coagulation Function Blood Biomarkers; | — |
Countries
China
Contacts
Huzhou Third Municipal Hospital