MDD with high risk and subthreshold of mania
Conditions
Interventions
Antidepressant medication group:Antidepressant medication
Interpersonal and social rhythm therapy with antidepressants‘ group:Interpersonal and social rhythm therapy with antidepressants
Antidepressant combined with lithium group:Antidepressant combined with lithium
Natural follow-up group:Follow up
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years old; (2) Meet the DSM-5 diagnostic criteria for depression; (3) High-risk bipolar or subliminal mania in the past; (4) The current HAMD-17 score is greater than 17; (5) No medication or stable medication for 2 weeks before enrollment; (6) Right-handed; (7) The patient or guardian signs an informed consent form; (8) Bipolar high risk: family history of bipolar disorder (first-level or second-level family members); (9) Subliminal mania meet DSM-5 "other specific bipolar related disorders"
Exclusion criteria
Exclusion criteria: (1) Meet any of the following diagnostic criteria (schizophrenia or other psychotic disorders, bipolar disorder, dementia or any other neurodegenerative diseases, alcohol or substance dependence, any mental illness caused by physical diseases or drugs) (2) Severe suicidal tendency, the third item of HAMD-17>=3; (3) Night workers; people with acute or chronic renal failure; (4) Patients with liver cirrhosis or active liver disease; (5) The laboratory examination is abnormal and is judged to be clinically significant or the investigator believes that it affects the efficacy of the test or the safety of the subjects; (6) Suffering from severe or unstable physical diseases, including: neurological diseases (delirium, dementia, stroke, epilepsy, migraine, high intracranial pressure, craniocerebral surgery, etc.), congestive heart failure, angina, myocardial infarction, Arrhythmia, hypertension (including untreated or uncontrollable hypertension), apnea syndrome, malignant tumor, immunocompromised subjects and subjects with blood sugar higher than 12mmol/L; (7) People who abused alcohol within 30 days before the start of the test or were dependent on alcohol or drugs within 6 months before the test; (8) Pregnant women, lactating women, and women of childbearing age who have a positive urine HCG test result during screening. (9) Male and female subjects who have not taken effective contraceptive measures or plan to become pregnant within 3 months after the start of the trial; (10) Those who have claustrophobia, etc. who cannot accept fMRI examinations (only subjects who participate in functional magnetic resonance scanning); (11) The investigator believes that there are other situations that are not suitable for participating in the clinical trial; (12) Unable to read and understand the information form, informed consent form or patient self-assessment questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy;Side-effect; | — |
Countries
China
Contacts
Public ContactWu Hong
Shanghai Mental Health Center
Outcome results
None listed