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Major Depressive DisorderECT MDDNCT06439797

Inflammatory Markers as Predictors of the Efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients

An observational study of Major Depressive Disorder and Healty Controls, run by The Chaim Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: ECT is an effective treatment indicated for patients with treatment resistant depression. Although most patients display some degree of recovery, 32-52% do not respond or remit at all. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Major Depressive Disorder, Healty Controls
How many people
18 participants
Where
1 siteIsrael
Study dates
29 Nov 2018to 9 Jul 2020
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 18 to 70 years
  • All sexes
  • Adult, Older adult

Study population: Major Depressive Disorder with treatment-resistant disorder referred to the ECT clinic

Who may be able to join

  • Capable and willing to provide informed consent. Able to adhere to the treatment schedule. Are treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF (antidepressant treatment history form) instruction guidelines.

Who cannot join

  • Diagnosis of an autoimmune disease. History of disturbances with bone marrow functioning. History of Oncologic Diseases. History of drug abuse or alcoholism in the last 6 months. Suffering from another diagnosis on axis 1, including schizophrenia, and geriatric depression.
  • Patients with any current unstable medical illness. Any condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, cardiac symptoms or disease, and renal or hepatic dysfunction Patients taking lithium or corticosteroids. Pregnancy or not using a reliable method of birth control. Neurodegenerative diseases (i.e: Alzheimer's disease, Parkinson's disease). Participation in a current interventional clinical study or interventional clinical study within 30 days before this study.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Revital Amiaz

    Ramat Gan, RI, 52621

Other trials in Israel

About this study

Background: ECT is an effective treatment indicated for patients with treatment resistant depression. Although most patients display some degree of recovery, 32-52% do not respond or remit at all. Considering the possible side effects and the considerably high cost of treatment, it is important to identify sub-populations that would benefit the most from ECT. In the current study we sought to identify predictive molecular markers in the blood of depressed patients who are responsive to ECT.

Methods: Patients, ages 18-70, with the diagnosis of treatment-resistant depression will be recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments will include the Montgomery-Asberg Depression Rating Scale (MADRAS), Clinical Global Improvement and Severity Scales (CGI-S, CGI-I), Inventory of Depressive Symptomatology (IDS), and the State-Trait Anxiety Inventory (STAI). Blood samples for serum and isolation of peripheral blood mononuclear cells (PBMCs)will be collected at baseline and the 12-week end-of-treatment time points for molecular analysis.

Read the detailed description

Despite impressive progress in our understanding of the molecular, cellular and circuit-level correlates of major depression, the biological mechanisms that causally underlie this disorder remain unclear, hindering the development of effective novel therapeutic procedures. One possible reason for this situation is that almost all research in this area focuses on the involvement of abnormalities in neuronal functioning, whereas the involvement of non-neuronal brain cells, particularly microglia, has not been thoroughly investigated. Recent studies indicate that impairments of the normal structure and function of microglia, caused by either intense inflammatory activation or by decline and senescence of these cells, can lead to depression and associated impairments in neuroplasticity and neurogenesis. Accordingly, we argued that at least some forms of depression can be considered as microgliopathies, in which either microglial activation or microglial decline and suppression constitute the direct etiology of the depressive syndrome. This implies that depression cannot be treated uniformly but should rather be treated by a personalized medical approach based on the microglial status of the individual depressed patient (Yirmiya et al., TiNS, 2015). In the current proposal we aim to lay foundations for a thorough examination of the personalized medical approach to depression, by examining the benefits of personalized utilization of anti-depressive procedures based on screening for inflammatory/ microglial markers, and by developing state-of-the-art tools for microglia manipulations that will allow to directly examine the causal role of these cells in various animal models of depression.

We specifically aim to develop a personalized approach to the utilization of electroconvulsive therapy (ECT), because our preliminary findings in a mouse model of depression associated with impaired microglia functioning conclusively show that ECT-induced microglia activation is causally related to the anti-depressive effects of this treatment. We propose to utilize a translational approach, assessing the inflammatory/microglia-related molecular factors (measured before treatment) that predict and contribute to the efficacy of ECT in major depression patients. Specifically, we expect that ECT will be more beneficial in patients with low expression of inflammatory/microglia-related genes, and thus based on the findings of this experiment we shall be able to devise a molecular screening for the suitability of ECT (and possibly other anti-depressant procedures) for the individual depressed patient. Furthermore, we aim to establish the transcriptomic effects of ECT, with a particular emphasis on inflammatory-related pathways. We expect differential transcriptomic effects of ECT in patients with high vs. low baseline inflammatory status. The results should significantly contribute to our knowledge regarding the molecular mechanisms that underlie the therapeutic effects of ECT in specific sub-groups of depressed patients.

In parallel studies we aim to develop molecular tools for selective and region-specific microglia activation or inhibition and to use these tools for: 1) examining the effects of these manipulations in animal models of depression that involve either hyper-or hypo-activity of microglia. 2) defining the causal role of microglia in mediating the anti-depressive effects of ECT in a depression model associated with low microglia status. These studies should complement the clinical part in humans, by providing definitive evidence for the inverted U-shape pattern of relations between inflammatory status and depression, which constitutes the basis for the personalized medical approach to this disease.

Medical subject headings
Depressive Disorder, Major

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory Markers as Predictors of the efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients.

    Patients, ages 18-70, with the diagnosis of treatment-resistant depression will recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments included the Montgomery-Asberg Depression Rating Scale (MADRAS), Clinical Global Improvement and Severity Scales (CGI-S, CGI-I), Inventory of Depressive Symptomatology (IDS), and the State-Trait Anxiety Inventory (STAI). Blood samples for serum and isolation of peripheral blood mononuclear cells (PBMCs) will be collected at baseline and the 12 weeks end-of-treatment time points for molecular analysis.

    Measured: Before ECT treatment and after 12 treatments, After 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start29 Nov 2018
  3. Primary completion9 Jul 2020
  4. Study completion9 Jul 2020

Resources

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-control
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439797
Sponsor's protocol ID
5040-18-SMC
Acronym
ECT MDD
Status last verified
May 2024
First submitted
28 May 2024
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder and Healty Controls, run by The Chaim Sheba Medical Center at 1 site in Israel.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 2024. 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 Israel. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Markers as Predictors of the efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients. (time frame: Before ECT treatment and after 12 treatments, After 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Jun 2024.

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