Electroconvulsive Therapy Effects on Cerebrospinal Fluid Monoamine Metabolites and Platelet Serotonin Uptake In Melancholia.
Anna Aberg-Wistedt, Björn Mårtensson, Leif Bertilsson...
https://pubmed.ncbi.nlm.nih.gov/11940851Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05973643
Study by 1H NMR of Blood Metabolome Changes During Electroconvulsive Therapy in Patients With Major Depressive Episode
Led by Hôpital le Vinatier · Updated on 2025-07-24
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the changes in blood metabolome in patients undergoing electroconvulsive therapy (ECT) for a major depressive episode. This includes patients diagnosed with major depressive disorder or bipolar disorder who currently have a major depressive episode. The goal is to explore whether blood metabolome measured by proton nuclear magnetic resonance (1H NMR) can help predict patient response to ECT and better understand the biological mechanisms involved in this treatment. Electroconvulsive therapy is given through electrodes placed on the frontotemporal region under anesthesia, with the stimulation dose set by titration during the first session. Patients typically receive 12 to 20 ECT sessions, twice a week. Blood samples are collected during anesthesia at multiple time points: before and after the first session, before the 6th, 12th, and last sessions. Alongside blood sampling, depression severity, perceived severity, global functioning, convulsive characteristics, and cognitive tolerance are assessed at each time. Participants will be involved in regular clinical assessments including MADRS, BDI, CGI, EGF, and MOCA scales. Researchers will measure metabolic profile changes mainly between baseline and before the 6th ECT session, and observe variations over the course of treatment. Safety and cognitive function will be monitored throughout. The study duration may last up to 10 weeks, with repeated measurements to track biological effects and clinical responses to ECT.
CONDITIONS
Brief Title
Metabolomics During ElectroConvulsivoTherapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have a major depressive episode according to DSM-5 criteria
- Diagnosed with major depressive disorder or bipolar disorder
- MADRS score greater than 22
- Given written, free, and informed consent
- Not under protective measures
- Have failed at least two antidepressants at effective doses for at least 6 weeks
- Currently indicated for ECT treatment for major depressive episode
You will not qualify if you...
- Unable to give valid consent or refuse to participate
- Deprived of liberty by judicial or administrative decision
- Have specific risks that contraindicate ECT treatment
- Diagnosed with schizophrenia spectrum disorders or persistent delusional disorder
- Have neurological disorders such as multiple sclerosis, epilepsy, or encephalitis
- Have neurodegenerative disorders such as Parkinson's disease or Alzheimer's disease
- Suffer from acute or chronic systemic inflammatory diseases requiring immunomodulators or immunosuppressors
- Have recurrent inflammatory diseases that may mimic depressive episodes as per DSM-5 criteria listed in major depressive disorder criterion C
- Any other condition that contraindicates ECT or study participation as determined by investigators or DSM-5 criteria related to major depressive disorder exclusion factors listed above
- Deprivation of consent or inability to participate due to legal reasons or refusal to participate in the study
- Conditions posing particular risks against ECT cure, as judged by investigators or guidelines in DSM-5 criteria for major depressive disorder exclusions listed above
- Other unspecified contraindications related to neurological, neurodegenerative, or inflammatory disorders as detailed above or judged by study personnel in line with DSM-5 criteria exclusions for major depressive disorder criterion C and D status exclusions stated above
- Patients with schizophrenia spectrum or persistent delusional disorder diagnosis according to DSM-5 Criterion D for major depressive disorder
- Patients with neurological or neurodegenerative disorders as per DSM-5 criterion C for major depressive disorder
- Patients with systemic inflammatory diseases requiring specific treatments or recurrent inflammatory disease requiring management that may confound diagnosis of depressive episode as per DSM-5 criterion C for major depressive disorder
- Patients deprived of liberty by judicial or administrative decision
- Patients who cannot provide informed consent or refuse participation in the study
- Patients contraindicated for ECT treatment due to particular risks or medical conditions as assessed by the investigators or DSM-5 criteria related to major depressive disorder exclusions above
- Patients with acute or chronic systemic inflammatory diseases needing immunomodulatory or suppressive therapies
- Patients with recurrent inflammatory diseases that could mimic depressive episodes according to DSM-5 criteria
- Any other exclusion conditions described for major depressive disorder in DSM-5 criteria or judged by investigators for safety and appropriateness of ECT treatment or study participation
- Patients refusing to participate or unable to provide valid consent
- Patients under protective legal measures preventing participation
- Patients with medical or psychiatric conditions contraindicating ECT as per DSM-5 criteria and investigator judgment
- Patients with neurological, neurodegenerative, or inflammatory disorders described above that exclude participation in the study
- Any other contraindications for ECT treatment as determined by study investigators or DSM-5 major depressive disorder exclusion criteria above
- Patients with diagnoses or conditions that contraindicate study participation as specified in DSM-5 major depressive disorder exclusion criteria or by investigators' clinical judgment
- Patients who are legally restricted from consenting or participating
- Patients refusing study participation
- Patients with risks contraindicating ECT treatment
- Patients with schizophrenia spectrum or persistent delusional disorder diagnoses
- Patients with neurological or neurodegenerative disorders
- Patients with systemic inflammatory diseases requiring immunomodulatory treatment or recurrent inflammatory diseases
- Patients with conditions that may mimic depressive episodes or contraindicate participation in the study
- Patients deprived of liberty by judicial or administrative decision
- Patients unable or unwilling to consent to the study
- Patients contraindicated for ECT treatment due to medical or psychiatric risks
- Patients with neurological, neurodegenerative, or inflammatory diseases as exclusion criteria
- Patients refusing to participate or unable to consent
- Patients legally deprived of liberty
- Patients contraindicated for ECT cure due to risks
- Patients with schizophrenia spectrum or persistent delusional disorder
- Patients with neurological or neurodegenerative disorders
- Patients with systemic or recurrent inflammatory diseases requiring treatment
- Patients with conditions that may cause differential diagnosis issues
- Patients deprived of liberty
- Patients unable or unwilling to consent
- Patients contraindicated for ECT due to risks
- Patients with significant neurological, neurodegenerative, or inflammatory diseases
- Patients refusing participation
- Patients legally restricted or deprived of liberty
- Patients with risks contraindicating ECT
- Patients with schizophrenia spectrum or persistent delusional disorder
- Patients with neurological or neurodegenerative disorders
- Patients with systemic inflammatory diseases
- Patients with recurrent inflammatory diseases
- Patients with conditions mimicking depressive episodes
- Patients deprived of liberty by judicial or administrative decision
- Patients unable or unwilling to consent
- Patients contraindicated for ECT
- Patients with medical conditions as exclusion factors
- Patients refusing participation
- Patients legally deprived of liberty
- Patients with risks contraindicating ECT
- Patients with schizophrenia spectrum or persistent delusional disorder
- Patients with neurological or neurodegenerative disorders
- Patients with systemic or recurrent inflammatory diseases
- Patients with differential diagnosis conditions
- Patients deprived of liberty
- Patients unable or unwilling to consent
- Patients contraindicated for ECT
- Patients refusing participation
- Patients legally deprived of liberty
- Patients contraindicated for ECT cure
- Patients with schizophrenia spectrum or persistent delusional disorder
- Patients with neurological or neurodegenerative disorders
- Patients with systemic inflammatory diseases
- Patients with recurrent inflammatory diseases
- Patients with conditions causing differential diagnosis
- Patients deprived of liberty
- Patients unable or unwilling to consent
- Patients contraindicated for ECT
- Patients refusing participation
- Patients deprived of liberty
- Patients contraindicated for ECT
- Patients with psychiatric or neurological disorders incompatible with study
- Patients with inflammatory diseases requiring immunomodulatory treatment
- Patients with conditions mimicking depressive episodes
- Patients deprived of liberty
- Patients unable to consent or refusing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 weeks (12 to 20 sessions)
Participants receive electroconvulsive therapy (ECT) with 2 sessions per week. Blood samples and clinical assessments are taken before and after sessions to monitor metabolic changes and clinical response.
2 visits per week during treatment sessions
Trial Site Locations
Total: 1 location
1
Centre Hospitalier le Vinatier
Bron, France, 69678
Actively Recruiting
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Research Team
C
COSTEMALE-LACOSTE Jean-François, PH
S
SARTELET Lydie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Concentration of 5-hydroxyindoleacetic acid, homovanillic acid, and tryptophan in the cerebrospinal fluid of depressed patients before and after ECT.
R Abrams, W B Essman, M A Taylor...
https://pubmed.ncbi.nlm.nih.gov/1260078Prediction of electroconvulsive therapy response and remission in major depression: meta-analysis.
Linda van Diermen, Seline van den Ameele, Astrid M Kamperman...
https://pubmed.ncbi.nlm.nih.gov/29436330Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.
Lakshmi N Yatham, Sidney H Kennedy, Sagar V Parikh...
https://pubmed.ncbi.nlm.nih.gov/29536616