An observational study in Major Depressive Disorder and Healty Controls, sponsored by The Chaim Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by The Chaim Sheba Medical Center · Observational
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.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 18 is below the median of 131 across 400 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →The Chaim Sheba Medical Center is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Major Depressive Disorder with treatment-resistant disorder referred to the ECT clinic
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Exclusion Criteria:
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 . Pregnancy or not using a reliable method of . 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Before ECT treatment and after 12 treatments, After 3 weeks
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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