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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06100302
Other study ID # XJTU1AF2022LSK-249
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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