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Objective:To assess the psychometric properties of the Chinese version of 12-item immediate mood scale(IMS-12) in patients with depression.Methods:From January to June 2018, a total of 459 patients with depression recruited from an outpatient clinic by convenient sampling approach.All the subjects were assessed by the Chinese version of the IMS-12, and 43 of them were assessed again at the end of the first week.The 16-item quick inventory of depressive symptomatology (QIDS-SR16), and the generalized anxiety disorder scale-7(GAD-7) were used as validity indicator.The factor structure of the scale was evaluated by exploratory and confirmatory factor analyses.The internal consistency of the Chinese version of the IMS-12 scale was evaluated by Cronbach’s alpha coefficient.The intraclass correlation coefficient (ICC) was used to evaluate test-retest reliability.Pearson’s correlation coefficient was used to evaluate calibration validity.The softwares of SAS 9.4 and Mplus 8.5 were used for statistical analysis.Results:The exploratory factor analysis indicated that the fitting result of the two-factor model was good(including depression and anxiety factors). The results of the confirmatory factor analysis indicated that the factor model fit well and met the reference standard ( χ2/ df=2.82, CFI=0.936, TLI=0.920, RMSEA=0.088). The Cronbach’s alpha coefficient of the Chinese version of the IMS-12 was 0.95, and the ICC for test-retest reliability was 0.85.The correlation coefficients of the total IMS-12 score with the QIDS-SR16 score and with the GAD-7 score were 0.69 and 0.70, respectively. Conclusion:The Chinese version of the IMS-12 has good reliability and validity and is suitable for the clinical assessment of depressive and anxiety symptoms in patients with depression.
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Objective To investigate the effects of single i.v. subanesthetic dose of ketamine on heart rate, blood pressure and oxygen saturation for antidepressant treatment. Methods Patients with severe depressive disorder were randomized to ketamine group (n=13) and control group (n=14). Ketamine group received ketamine (0.5mg/kg) single injection whereas control group received saline single injection. Escitalopram (10 mg/d) were orally administered for 4 weeks simultaneously. Comparisons were made on the heart rate, blood pressure and oxygen saturation at baseline, 40 min, 100 min, and 280 min after injection between the two groups. Results The main effects of time but not group were significant for all parameters including heart rate, systolic blood pressure and diastolic blood pressure, (P＜0.05). Interaction of time×group was significant (P＜0.05). All parameters including heart rate (F=16.85, P＜0.01), systolic blood pressure (F=15.82, P＜0.01) and diastolic blood pressure (F=8.63, P＜0.01) with time were significant in ketamine group. The heart rate, systolic blood pressure and diastolic blood pressure in ketamine group were significantly higher at 40 min than at other time points (P＜0.05), while were no significant difference among other time points (P＞0.05). There was no statistical significance of main effect of time, group and interaction of time×group in oxygen saturation between the two groups (P＞0.05). Conclusion Single subanesthetic dose ketamine intravenous drip for antidepressant therapy may cause a transient increase in heart rate and blood pressure.
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Objective To promote the Institutional Review Board(IRB) construction and development via paying more attention to the detail management and providing better protection of subjects' rights and interests in ethical review of clinical trials and scientific research projects.Methods Assessment criteria were established according to the domestic and international laws and regulations on the management of ethical and scientific research project.Ethical site visit was performed on the 37 clinical trials/scientific research projects approved by IRB during the year 2012-2015.Results Clinical trials/scientific research projects were divided into tree types:the registered clinical trials,the post-marketing clinical trials and the researcher initiated scientific research project.All the types met with the following assessment criteria:satisfy the requirement of equipment,facilities and qualifications of drug preservation required for conducting clinical research;subjects were given compensation according to the protocol;informed consent were obtained.Among them,the registered clinical trials meet more criteria than other research types.Regarding to the standard of informed consent implementation,all types met with the following assessment criteria:all the subjects enrolled signed informed consent forms,informed consent forms are well documented;investigators and subjects/ the guardian signed the forms.However,during the site visit,some other criteria were also neglected more or less.Particularly,only few project recorded the consent process and time spots singed the forms.Conclusions Investigators should pay more attention to the activities and behaviors taken place during the research implementation process.Researchers and management staffs should pay attention to ethical detail management to guarantee better protection of subjects' rights and interests.