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

NCT ID: NCT05597566

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depression Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Elderly depression patients with suicidal ideation

Conformity: Age 60-85 years old; meet DSM-5 diagnostic criteria for major depressive disorder; currently in acute phase, HDRS-17 ≥ 24; history of suicide attempt in this depressive episode; current suicidal ideation, SIOSS ≥ 12.Exclusions: Patients with unstable physical diseases; patients currently suffering from acute inflammatory infection or chronic inflammatory disease; participated in another interventional clinical study within the past 1 month; previous or current diagnosis of other psychiatric diseases by DSM-IV ; abuse of alcohol and active drugs within 12 months, except for nicotine; severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation; MECT treatment contraindications; pregnant, lactating women or planning pregnancy; allergic to propofol and succinylcholine chloride.

modified electroconvulsive therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qinge Zhang

OTHER

Sponsor Role lead

Responsible Party

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Qinge Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qing e Zhang, PhD

Role: STUDY_CHAIR

Beijing Anding Hospital Affiliated to Capital Medical University

Locations

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Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Man Liu

Role: CONTACT

+8658340200

Facility Contacts

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Qing e Zhang, PhD

Role: primary

+8658340200

References

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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 epidemiological survey in Beijing, China. J Affect Disord. 2015 Jul 1;179:74-81. doi: 10.1016/j.jad.2015.03.009. Epub 2015 Mar 14.

Reference Type RESULT
PMID: 25845752 (View on PubMed)

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 and middle income countries. J Affect Disord. 2016 Jan 15;190:362-368. doi: 10.1016/j.jad.2015.09.004. Epub 2015 Oct 23.

Reference Type RESULT
PMID: 26544620 (View on PubMed)

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. 2018 May 30. doi: 10.1002/gps.4917. Online ahead of print.

Reference Type RESULT
PMID: 29851173 (View on PubMed)

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;138(3):223-231. doi: 10.1111/acps.12942. Epub 2018 Jul 12.

Reference Type RESULT
PMID: 30003550 (View on PubMed)

Other Identifiers

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KM202010025011

Identifier Type: -

Identifier Source: org_study_id

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