An observational study in Depression, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Shanghai Mental Health Center · Observational
According to the survey of the World Health Organization, the number of patients with depression in the world has reached 350 million, has becoming the primary cause of disability and the main disease burden worldwide. In order to better dealing with adverse reactions, improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick evaluation scales to evaluate the influence, doctor-patient relationship and social and economic benefits after drug treatment in clinical treatment. At present, the reliability and validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of the above three scales in depressive disorder, aiming at enriching the treatment of depressive patients based on assessment, thus improving the compliance of medication for depressive disorder, improving the doctor-patient relationship and reducing the total burden of social diseases.
In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the diversity and selectivity of domestic assessment tools.
This study includes two steps.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 120 is below the median of 158 across 1,111 observational studies indexed under Depression.
Browse Depression studies →Shanghai Mental Health Center is the lead sponsor of 271 studies on the registry; 90 are open to participants now.
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Depressive disorder group: The samples were from the outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New Area Mental Health Center from January 2020 to December 2020, and met DSM-5 diagnostic criteria. Sixty patients aged 1865 were enrolled in the group.
Healthy control group: The sample comes from the healthy people recruited by the society who meet the entry criteria of the control group and match the gender, age and education level, and 60 cases are planned to be enrolled in the group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Case group:
Control group:
1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with junior high school education or above. 3）Willing to participate in this study, and the subjects signed the informed consent form.
Exclusion Criteria:
- 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects the validity of neuropsychological test data.
3）serious negative suicide concept.
Treatment Emergent Symptom Scale TESS
Common adverse drug reactions and signs were evaluated. The "severity" column was used to evaluate the severity level of symptoms from 0 to 4. The higher the severity level, the more serious the symptoms
Time frame: Up to 1 week
The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER
Evaluate three areas of drug side effects through patient self-report and rank the drug impact: frequency (how many adverse reactions caused by depression drugs in the past week), intensity (how serious adverse reactions caused by depression drugs in the past week), and burden (how much adverse reactions caused by depression drugs affect your daily activities in the past week).
Time frame: Up to 4 week
HEA Health Economics Follow-up Evaluation Form，HEA
The main evaluation in the past month includes the following items: how many times have you seen a doctor (doctor), other medical personnel, whether you have been in hospital, and the number of days off due to depression and other diseases
Time frame: Up to 4 week
Sheehan Disability Scale ，SDS
Including three items, ask patients about the degree of damage caused by their current diseases/symptoms to their work, social interaction and family functions in turn; Visual simulation score of 0-10
Time frame: Up to 1 week
Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)
The total score of STAR-P and the scores of three subscales are adopted: active collaboration (PCO: harmonious and shared understanding of goals and mutual open and trusted experiences), active clinician input (PCI: clinicians encourage, consider, support, listen and understand patients) and non-clinician input (NCI: patients can't understand clinicians), which is composed of 12 items
Time frame: Up to 4 week
PDRQ-15 Scale
There are 15 items in total, which are divided into three dimensions: patient/family satisfaction (6 items), accessibility of medical staff (7 items) and disease attitude of patients/family members.
Time frame: Up to 1 week
HAM-D
To evaluate the severity of depressive symptoms by clinicians. Remission: total score \< 7.
Time frame: Up to 4 week
HAM-A
To evaluate the severity of anxiety symptoms by clinicians. The total score \< 6: no anxiety sympotom.
Time frame: Up to 4 week
YMRS
Assess symptoms of mania,the total score \< 6: no mania sympotom.
Time frame: Up to 4 week
Ran from Jul 2020 to primary completion in Oct 2021, 14 months.
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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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