An observational study in Major Depressive Disorder, sponsored by Zhang Yan. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by Zhang Yan · Observational
This experiment intends to explore the differences among various types of depression, as well as the differences between healthy subjects and depressed patients, and find possible biological markers from the severity of symptoms, social function and cognitive function of depressed patients, combined with EEG characteristics, biological test indicators (blood, faeces, hair, etc.) and functional magnetic resonance imaging data.
To explore the changes in clinical symptoms, cognitive and social functions, and biological indicators of various types of patients before and after treatment, to provide references for the prognosis of various types, and to predict the future development of the disease according to the baseline indicators of patients; According to the above aspects, this experiment can follow up the patients with depression, track their disease development, and study the potential biological changes in the early stage of the disease, which has the potential to reveal the pathogenesis and provide guidance for the early diagnosis and intervention of depression.
More specifically, the goals of this study are to 1) explore the potential biomarkers for Major Depressive Disorder by comparing MDD patients and healthy controls; 2) investigate the biochemical indicators for subtypes of MDD through long-term cohort follow-up studies; 3) investigate the differences and similarities among different types of MDD patients in terms of cognitive functions, biological tests, as well as neuroimaging data; 4) evaluate and analyze the prognosis of patients according to the baseline level, and search for the biomarkers regarding MDD treatment response to guide the clinical treatment and intervention of patients with MDD; 5) Through the long-term follow-up study, the behavioural and biochemical indicators of the patients with MDD were collected, the differences between the indicators before and after remission were examined, and the state and quality of the pathophysiological indicators of the patients with MDD were investigated.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 480 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →This is the only study on the registry with Zhang Yan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Samples are taken from depressed patients in outpatient and inpatient departments of hospitals and recruited health care workers.
480 subjects are expected to be collected and divided into two groups, 180 healthy subjects and 300 experimental subjects.
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Exclusion Criteria:
Change in Hamilton Depression Rating Scale-24 item (HAMD-24)Interview-based questionnaire used to measure the severity of depression
Consists of 24 items with a score calculated. Higher scores are associated with more severe depression.
Time frame: 8weeks
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)Interview-based questionnaire used to measure the severity of depression.
Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)Interview-based questionnaire used to measure the severity of anxiety.
Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in DSST (Number of Correct Symbols)
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 aims to assesses the severity of anxious symptoms.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 aims to assesses the severity of depression symptoms.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
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