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

October 24, 2022 updated by: Qinge Zhang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Anding Hospital Affiliated to Capital Medical University
        • Contact:
          • Qing e Zhang, PhD
          • Phone Number: +8658340200
          • Email: zqe81@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects were from elderly patients with depression who were hospitalized in Beijing Anding Hospital Affiliated to Capital Medical University.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change level of IL-6 compared with baseline at the end of MECT treatment.
Time Frame: baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change level of IL-1β compared with baseline at the end of MECT treatment.
Time Frame: baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
Serum IL-1β 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qinge Zhang

Investigators

  • Study Chair: Qing e Zhang, PhD, Beijing Anding Hospital Affiliated to Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM202010025011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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