Major depressive disorder
Conditions
Interventions
Depression group:The research is carried out in two stages. A total of 120 MDD participants were recruited in the first stage of the prospective observational cohort. During the observation period, MD
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
9 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 9–18 years, outpatients at Shanghai Sixth People’s Hospital, either sex; 2. Diagnosed with single-episode or recurrent major depressive disorder in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), via initial assessment using the Mini-International Neuropsychiatric Interview (M.I.N.I.); 3. Hamilton Depression Rating Scale-17 (HAMD-17) total score >= 20 at screening; 4. Negative result on the Mood Disorder Questionnaire (MDQ) at screening; 5. No psychiatric medication use, or continuous use of psychiatric medication for less than 14 days prior to screening; 6. Voluntary participation with written informed consent obtained from a legal guardian.
Exclusion criteria
Exclusion criteria: 1. Presence of any other psychiatric disorder aside from major depressive disorder; 2. Organic psychiatric disorders or major depressive episodes secondary to neurological or systemic diseases; 3. Developmental disorders, including attention-deficit/hyperactivity disorder (ADHD), IQ <=70 or intellectual disability, autism spectrum disorder, significant reading disorder, and tic disorders; 4. High risk of suicide (defined as a suicide attempt within the past year, or a score of moderate or severe on item 3 "Suicide" of the HAMD); 5. Severe physical illnesses, such as cardiac, respiratory, hematological, hepatic, renal, endocrine, or neurological diseases, or other systemic conditions; diagnosis of gastrointestinal diseases (e.g., tumors, inflammatory bowel disease, diarrhea, constipation, etc.); 6. Clinically significant abnormalities in laboratory tests (including ECG); 7. Use of antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), probiotics, corticosteroids, immunosuppressants, immunomodulators, or proton pump inhibitors within the past 3 months; 8. Substance dependence (excluding nicotine) within the past 6 months; 9. Severe or unstable general medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAMD-17 score at week 8 compared to baseline in MDD subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate and remission rate at week 8; | — |
Countries
China
Contacts
Public ContactBian Qian
Shanghai Sixth People's Hospital
Outcome results
None listed