Major Depressive Disorder/Insomnia Disorder
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: Control Group: a. The structured clinical interview for DSM disorders in Chinese version, administered by the Simplified International Neuropsychiatric Interview, does not meet the diagnostic criteria for any mental illness. b. Participants are aged between 19 and 65. c. They voluntarily participate in the study and sign an informed consent form. Depression Group: Inclusion criteria: a. Diagnosed with major depressive disorder according to DSM-5 criteria, with at least a moderately severe depressive episode, by two professional psychiatrists (after 2 weeks of training). b. Exclusion of other mental disorders through the Mini-International Neuropsychiatric Interview (M.I.N.I.) Chinese version 5.0.0 structured interview. c. Participants are aged between 19 and 65. d. Scoring =17 on the Hamilton Depression Scale-17 (HAMD-17). e. They voluntarily participate in the study and sign an informed consent form. Insomnia Group: Inclusion criteria: a. Self-reported insomnia symptoms and confirmation of meeting DSM-5 criteria for insomnia disorder through the Mini-International Neuropsychiatric Interview (M.I.N.I.) Chinese version 5.0.0 structured interview. b. Participants are aged between 19 and 65. c. Scoring =8 on the Pittsburgh Sleep Quality Index (PSQI). d. Total score on the Hamilton Anxiety Scale-14 (HAMA-14) =14. e. Total score on the Hamilton Depression Scale-17 (HAMD-17) =17. f. Negative screening on the Chinese version of the Mood Disorder Questionnaire (MDQ) and the Hypomanic Checklist-32 (HCL-32) for hypomanic symptoms. g. They voluntarily participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the Healthy Control Group: a. Having severe somatic diseases and organic brain diseases. b. Having serious injuries, infections, traumas and a history of surgery in the past three months. c. Existing contraindications for PET-MRI scan. d. Long-term consumption (at least 5 times a week) of probiotics or prebiotics, drugs or beverages in the past month. e. Use of antibiotics in the past three months. f. Having severe diarrhea (= 3 times/day for = 3 days) or severe constipation (= 2 times/week, with difficulty in defecation) in the past three months. Exclusion criteria for the Depression Group: Same as the control group and additionally, g. Use of any psychotropic drugs or health products in the past two weeks. Exclusion criteria for the Insomnia Group: a. The presence of other comorbid sleep-wake disorders based on the multi-lead sleep monitoring results. b. Same as b to f as in control group. d. Use of any psychotropic drugs or health products in the past two weeks. e. Having traveled across time zones or shift work (night to day shift) in the past week; f. Regular daily drinking of excessive tea, alcohol, or coffee drinks. g. Same as g to j as in control group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET/CT normalized uptake value;Brain MRI;gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| metabonomics;polysomnography; | — |
Countries
China
Contacts
Public ContactLu Wang
The First Affiliated Hospital of Jinan University
Outcome results
None listed