Study on the Mechanism of Immune Inflammation in Cognitive Impairment of Depression

Depression Clinical Trial

— depression  

Official title:

The First Affiliated Hospital of Xi'an Jiaotong University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100302
• Other study ID #: XJTU1AF2022LSK-249
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jia M
• Phone: 02985324575
• Email: tsooung[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The patients with depression were observed and followed up to evaluate the changes of symptoms and cognitive function in patients with depression at different time points before and after drug treatment. At the same time, immunometabolism indicators in serum, urine and stool were detected to screen out immunoinflammatory markers related to cognitive function and treatment response in patients with depression, hoping to provide a new strategy for optimal treatment of depression.

Description:

1. Participants were included according to the inclusion and exclusion criteria, and demographic data of depressed patients and healthy controls were recorded, including age, sex, ethnicity, occupation, etc. Subjects in the depression group were treated with antidepressants (as recommended by the guidelines) and were followed up baseline, 2 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment, respectively. At each follow-up point, symptoms were assessed using Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Depression Screening Scale (PHQ-9) and Generalized Anxiety Scale (GAD-7), and cognitive function was assessed using Thinc-it at three follow-up points: baseline, 12 weeks after treatment, and 24 weeks after treatment. General data were compared between patients with depression and healthy controls at baseline.

2. The depression group was followed up. Serum and fecal of patients with depression were collected at 5 follow-up points at baseline, 2 weeks, 8 weeks, 12weeks and 24 weeks after treatment, and serum metabolic indexes and fecal metagenome were detected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2025
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• no-intervention
no-intervention

Locations

Country	Name	City	State
China	277 Yanta West Road	Xi'an	Yanta

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum metabolites	Metabolites in serum were quantified using LC-MS/MS. LC-MS/MS analyses were performed using a UHPLC system.	baseline?2weeks?8weeks?12weeks?24weeks
Other	Shotgun Metagenomic Sequencing and Metagenome-Wide Intestinal macrogene	Shotgun metagenomic sequencing and alignment methods were used to detect fecal flora diversity	baseline?2weeks?8weeks?12weeks?24weeks
Primary	Scores of Hamilton Depression Scale	Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores <7 is normal; Mild depression with total scores of 7~17; Moderate depression with total scores of 18~24; Total scores >24 for severe depression.	baseline?2weeks?8weeks?12weeks?24weeks
Primary	Scores of Hamilton Anxiety Scale	Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores< 7 indicates no anxiety; Total scores=7 indicates possible anxiety; Total scores=14 indicates anxiety; Total scores=21 indicates obvious anxiety; Total scores=29 points indicates serious anxiety.	baseline?2weeks?8weeks?12weeks?24weeks
Primary	Patient Health Questionnaire-9	Using to assess depression symptoms, scores range from 0~27, With higher scores associated with more severe depression symptoms. Total scores 0~4 indicates no depression; Total scores 5~9 indicates mild depression; Total scores 10~14 indicates moderate depression; Total scores 15~19 indicate moderate to severe depression; Total scores 20~27 indicates major depression.	baseline?2weeks?8weeks?12weeks?24weeks
Primary	Generalized self-rating anxiety Scale	Using to assess anxiety symptoms, scores range from 0~21. With higher scores associated with more severe anxiety symptoms. Total scores 5~9 indicates mild anxiety; Total scores 10~14 scores indicate moderate anxiety; Total scores 15~21 scores indicate severe anxiety.	baseline?2weeks?8weeks?12weeks?24weeks
Secondary	Thinc-it cognitive function test	The THINC-it tool is digitalized and completed by the respondent on a tablet is used to assess cognitive function in patients with MDD. Includes four objective test, Spotter (Choice Reactio Time), Symbol Check (1-back test), Trails (Trails Making Test B), and Codebreaker (Digit Symbol Substitution Test) as well as a self-reported cognitive function questionnaire (i.e., Perceived Deficit Questionnaire, 5-item).	basline?12weeks?24weeks
Secondary	Sheehan Disability Scale	It was used to evaluate the impairment of social function in three areas of work/school, social life and family life of patients with depression. 0~10 scores were used in each area, and the total score was 0~30 points. The higher the score, the more serious the impairment of function.	basline?12weeks?24weeks
Secondary	Pittsburgh Sleep Quality Index	Using to assess the sleep quality. Total scores of 0-5 indicates that the quality of sleep is very good, 6~10 indicates that the quality of sleep is OK, 11~15 indicates that the quality of sleep is average, and 16~21 indicates that the quality of sleep is poor.	baseline?2weeks?8weeks?12weeks?24weeks
Secondary	Gastrointestinal function scale	A rating scale for gastrointestinal symptoms in patients. It contains 16 items, total scores 16~112, each items is graded on a scale of 1~7, the higher total scores, the more severe the gastrointestinal symptoms.	baseline?2weeks?8weeks?12weeks?24weeks