Predictive Effect of Neuroinflammatory Factors of the MECT in Treatment of Senile Depression

Major Depression Disorder Clinical Trial

Official title:

Predictive Effect of Neuroinflammatory Factors on the Efficacy of Modified Electroconvulsive Therapy in the Treatment of Senile Depression Accompanied by Suicidal Ideation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597566
• Other study ID #: KM202010025011
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Capital Medical University
• Contact: Man Liu
• Phone: +8658340200
• Email: 473422818[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the correlation between the clinical efficacy of MECT treatment and baseline, 3 times, 8 times of treatment, 1 week after treatment, and 2 weeks after treatment in patients with depression and suicidal ideation. The prediction effect of -1β and IL-6 levels and level changes on the efficacy of MECT in the treatment of suicidal ideation in elderly patients with depression, and provide a theoretical basis for further research on the mechanism of MECT in the treatment of elderly depression with suicidal ideation.

Description:

Late-life depression is a common mental disorder, old age 40-70% of the patients with suicide ideation, modified electroconvulsive therapy can quickly improve part in elderly patients with depression commit suicide idea, but curative effect exist individual differences, looking for MECT treatment of elderly patients with depression, early predictors of treatment plan formulation has important clinical significance.A total of 72 elderly patients with depression with suicidal thoughts were included in this project, who were treated with MECT for 8 times. Blood samples, demographic data and clinical symptom assessment data were collected before treatment, 3 times, 8 times, 1 week and 2 weeks after treatment, and the levels of IL-1β and IL-6 were measured at each time point. To analyze the relationship between the levels of IL-1β and IL-6 at baseline and at each time point and the changes of clinical symptoms and suicide concept, and to explore the predictive effect of the levels and changes of IL-1β and IL-6 on the efficacy of MECT in the treatment of suicide concept in elderly patients with depression. To provide a reference for further research on the mechanism of MECT in the treatment of senile depression with suicide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

Provide written informed consent; Age 60 to 85 years old, including 60 and 85 years old; Meet the diagnostic criteria for single or recurrent major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition); Currently in the acute phase, with a total score of 17-item Hamilton Depression Rating Scale (HDRS-17) = 24 at baseline; History of suicide attempt in this depressive episode; Rating Scale (SIOSS)=12 points; Exclusion Criteria: Patients with a history of epilepsy or coronary heart disease or other serious unstable physical diseases; Patients with acute inflammatory infection or chronic inflammatory disease; Patients in the past 1 month Participated in another interventional clinical study; Past or current diagnosis of the following psychiatric diseases by DSM-IV: organic mental disorder, Alzheimer's disease, secondary dementia due to other causes, mental illness Schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder, unspecified mental illness, and patients with a history of drug abuse, including alcohol and active drug abuse in the past 12 months, except for nicotine; Severe aphasia , visual and hearing impairment, etc. who cannot complete the scale evaluation; Those who have contraindications to MECT treatment; Those who are pregnant, lactating women or planning to become pregnant; Those who are allergic to atropine, propofol, and succinylcholine chloride.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression Disorder

Intervention

Procedure:
• modified electroconvulsive therapy
The patient underwent MECT therapy. The treatment instrument is Xingmaitong IV ECT multifunctional treatment instrument (USA, SOMATICS THYMATRON company), fasting for 6 hours before surgery, emptying urine. Routine preoperative preparations were made, followed by intravenous injection of atropine, propofol, and succinylcholine chloride injection, artificial respiration, placement of dental pads, and electroconvulsive therapy. The whole process is completed by an anesthesiologist and a therapist in cooperation with each other. The first 3 times are once a day, and the next 5 times are once every other day. A total of 8 courses of treatment.

Locations

Country	Name	City	State
China	Beijing Anding Hospital Affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qinge Zhang

Country where clinical trial is conducted

China, 

References & Publications (4)

Carlier A, van Exel E, Dols A, Bouckaert F, Sienaert P, Ten Kate M, Wattjes MP, Vandenbulcke M, Stek ML, Rhebergen D. The course of apathy in late-life depression treated with electroconvulsive therapy; a prospective cohort study. Int J Geriatr Psychiatry — View Citation

Guerra M, Prina AM, Ferri CP, Acosta D, Gallardo S, Huang Y, Jacob KS, Jimenez-Velazquez IZ, Llibre Rodriguez JJ, Liu Z, Salas A, Sosa AL, Williams JD, Uwakwe R, Prince M. A comparative cross-cultural study of the prevalence of late life depression in low — View Citation

Liu J, Yan F, Ma X, Guo HL, Tang YL, Rakofsky JJ, Wu XM, Li XQ, Zhu H, Guo XB, Yang Y, Li P, Cao XD, Li HY, Li ZB, Wang P, Xu QY. Prevalence of major depressive disorder and socio-demographic correlates: Results of a representative household epidemiologic — View Citation

Obbels J, Verwijk E, Vansteelandt K, Dols A, Bouckaert F, Schouws S, Vandenbulcke M, Emsell L, Stek M, Sienaert P. Long-term neurocognitive functioning after electroconvulsive therapy in patients with late-life depression. Acta Psychiatr Scand. 2018 Sep;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change level of IL-6 compared with baseline at the end of MECT treatment.	Serum IL-6 levels were measured at baseline, 3 times of treatment, 8 times of treatment, 1 week of treatment and 2 weeks of treatment. At the same time, SIOSS, BSI-CV, HDRS-17 and MADRS were used to comprehensively evaluate the clinical symptoms of elderly patients with depression.	baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
Secondary	Change level of IL-1ß compared with baseline at the end of MECT treatment.	Serum IL-1ß levels were measured at baseline, 3 times of treatment, 8 times of treatment, 1 week of treatment and 2 weeks of treatment. At the same time, SIOSS, BSI-CV, HDRS-17 and MADRS were used to comprehensively evaluate the clinical symptoms of elderly patients with depression.	baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks