Understanding how immune inflammation affects cognitive function in depression
The First Affiliated Hospital of Xi'an Jiaotong University
This study looks at how inflammation in the immune system affects thinking skills in people with depression before and after they start taking antidepressants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Yanta) |
| Trial ID | NCT06100302 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients diagnosed with depression to evaluate changes in their symptoms and cognitive function over time, specifically before and after treatment with antidepressants. Participants will be assessed at multiple follow-up points using various scales to measure depression and anxiety levels, as well as cognitive function. Additionally, serum, urine, and stool samples will be collected to identify immunoinflammatory markers that may relate to cognitive function and treatment response, aiming to enhance treatment strategies for depression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 who meet the diagnostic criteria for depression and have not received antidepressant therapy for at least three months.
Not a fit: Patients with significant medical conditions, pregnant or lactating women, or those with a recent history of infections or anti-inflammatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for depression by identifying biomarkers associated with cognitive function.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have shown that understanding the relationship between immune function and cognitive impairment in depression can yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60 years old, male or female; * Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points; * Junior high school education and above, can cooperate with the completion of relevant scales and sample collection; * did not receive antidepressant therapy at admission or took medication for less than 14 days; And the duration of drug withdrawal ≥3 months; * No history of infection and taking hormones, antibiotics or anti-inflammatory drugs in the past 1 month; * History of physical diseases such as centerless, liver, kidney and gastrointestinal tract, active infection, active or chronic inflammation, autoimmune diseases, etc. Exclusion Criteria: * Pregnant and lactating women; * Clinically significant or unstable medical conditions, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases; * Patients with acute or chronic infection, taking anti-inflammatory drugs, cortisol hormones, and receiving antibiotics for 3 consecutive days in the past 1 month; * Patients with neuropsychiatric diseases other than depression.
Where this trial is running
Xi'an, Yanta
- 277 Yanta West Road — Xi'an, Yanta, China (Recruiting)
Study contacts
- Study coordinator: Jia M
- Email: tsooung@163.com
- Phone: 02985324575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.