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Characterisation of near-infrared brain function and intestinal flora in patients with perimenopausal depression

Characterisation of brain function and intestinal flora in patients with perimenopausal depression

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086303
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal depression

Interventions

Perimenopausal depression group:None
Non-perimenopausal depression group:None
Normal control group:None

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Perimenopausal depression group: 1. Female, aged between 18 and 65 years old; 2. Meets DSM-5 diagnostic criteria for major depressive disorder and the subject is in perimenopause with a Hamilton Depression Scale (HAMD-17) score >17; 3. No use of anti-anxiety drugs, antidepressants, antipsychotics or anticonvulsants in the last 1 month; 4. No use of prebiotics, probiotics and probiotic fermented foods within 1 month; 5. Not using any antibiotics in 1 month. Non-perimenopausal depression group: 1. Female, aged between 18 and 65 years old; 2. Meet the DSM-5 diagnostic criteria for major depressive disorder, and the subjects are in the non-perimenopausal period, with a Hamilton Depression Scale (HAMD-17) score > 17; 3. No use of anti-anxiety drugs, antidepressants, antipsychotics or anticonvulsants in the last 1 month; 4. No use of prebiotics, probiotics and probiotic fermented foods within 1 month; 5. Not using any antibiotics in 1 month. Normal control group: 1. Female, aged between 18 and 65 years old; 2. Do not meet the diagnostic criteria of DSM-5 major depressive disorder, Hamilton Depression Scale (HAMD-17) score = 7, and the subjects are in perimenopause; 3. No use of anti-anxiety drugs, antidepressants, antipsychotics or anticonvulsants in the last 1 month; 4. No use of prebiotics, probiotics and probiotic fermented foods within 1 month; 5. Not using any antibiotics in 1 month.

Exclusion criteria

Exclusion criteria: 1. People with organic brain lesions (such as cerebral haemorrhage, massive cerebral infarction, encephalitis, epilepsy); people with chronic systemic diseases that can affect the central nervous system and the digestive system; people with systemic systemic diseases (such as autoimmune diseases) that are not well controlled. 2. Those who suffer from inflammatory bowel disease, pancreatitis, gastrointestinal tumour and other digestive system diseases; 3. Obesity: BMI = 28.0; Hyperglycemia: FPG = 6.1mmol/L and/or 2hTC = 7.8mmol/L and/or those who have been diagnosed with diabetes mellitus and have been treated; TG = 2.3mmol/L; Hypertension: systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg; 4, Those with severe dietary imbalance, such as high-fat diet preference or long-term vegetarians; 5. Suffering from other mental disorders that meet the DSM-5 diagnostic criteria (except anxiety disorders and insomnia disorders); 6. Pregnant and lactating women; 7. Refusing to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Fecal sample test;

Secondary

MeasureTime frame
Near Infrared Brain Function Test;Hamilton depression scale;Hamilton Anxiety Scale;Self-rating depression scale;Self-Rating Anxiety Scale;Pittsburgh sleep quality index;Global Assessment Function;

Countries

China

Contacts

Public ContactYihuan Chen

Department of psychiatry, Xijing Hospital

chenyihuan12345@163.com+86 183 9213 5076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026