Major Depression DisorderNCT05597566
Predictive Effect of Neuroinflammatory Factors of the MECT in Treatment of Senile Depression
An observational study of Major Depression Disorder, run by Qinge Zhang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Major Depression Disorder
- What is being tested?
- modified electroconvulsive therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects were from elderly patients with depression who were hospitalized in Beijing Anding Hospital Affiliated to Capital Medical University.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Qing e Zhang, PhD, +8658340200, zqe81@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depression Disorder
- Being tested
- modified electroconvulsive therapy
- Keywords
- neuroinflammatory factors, modified electroconvulsive therapy(MECT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified electroconvulsive therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: modified electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
Change level of IL-1β compared with baseline at the end of MECT treatment.
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.
Measured: baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jun 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinge Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qinge Zhang, Capital Medical University
- Investigators
- Qing e Zhang, PhD, Study chair, Beijing Anding Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597566
- Sponsor's protocol ID
- KM202010025011
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25845752Guerra 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.
PubMed 26544620Carlier 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.
PubMed 29851173Obbels 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.
PubMed 30003550
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Effect of Neuroinflammatory Factors on the Efficacy of Modified Electroconvulsive Therapy in the Treatment of Senile Depression Accompanied by Suicidal Ideation
- ClinicalTrials.gov ID
- NCT05597566
- Acronym / sponsor ID
- KM202010025011
- Conditions
- Major Depression Disorder
- Keywords
- neuroinflammatory factors, modified electroconvulsive therapy(MECT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Qinge ZhangUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly depression patients with suicidal ideation | – | Procedure: modified electroconvulsive therapyConformity: 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were from elderly patients with depression who were hospitalized in Beijing Anding Hospital Affiliated to Capital Medical University.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified electroconvulsive therapyThe 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. | Procedure or surgery | Elderly depression patients with suicidal ideation |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Results publication: PubMed 25845752Liu 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.
- Results publication: PubMed 26544620Guerra 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.
- Results publication: PubMed 29851173Carlier 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.
- Results publication: PubMed 30003550Obbels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing e Zhang, PhD study chair
Beijing Anding Hospital Affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression Disorder, run by Qinge Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Man Liu (+8658340200, 473422818@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.