Clinical trial NCT05597566: Predictive Effect of Neuroinflammatory Factors of the MECT in Treatment of Senile Depression
Official title: Predictive Effect of Neuroinflammatory Factors on the Efficacy of Modified Electroconvulsive Therapy in the Treatment of Senile Depression Accompanied by Suicidal Ideation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depression Disorder
Keywords: neuroinflammatory factors
modified electroconvulsive therapy(MECT)
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change level of IL-6 compared with baseline at the end of MECT treatment.
timeFrame: baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
Secondary outcomes:
measure: Change level of IL-1β compared with baseline at the end of MECT treatment.
timeFrame: baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anding Hospital Affiliated to Capital Medical University
name: Qing e Zhang, PhD
role: STUDY_CHAIR
References:
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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;138(3):223-231. doi: 10.1111/acps.12942. Epub 2018 Jul 12.