Multimodal Biomarkers of Electroconvulsive Therapy in Severe and Treatment-resistant Depression

NCT05463562 | Unknown

• 1 other identifier: 21-1087
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Electroconvulsive therapy (ECT) is a widespread and safe stimulation method that has been used successfully for decades in psychiatric diseases such as severe or therapy-resistant depression. Unfortunately, ECT still has stigmas attached to it. The latter often leads to reservations among those affected and perturbs optimal and guideline-based therapy. Despite the demonstrated effectiveness of ECT, prediction of treatment response is still not possible. This is due to the limited knowledge about the biological mechanisms of action of ECT, especially on an individuum level. Thus, the DetECT study intends to recruit 134 inpatient subjects of the Max Planck Institute of Psychiatry with severe and/or treatment resistant depression receiving ECT to perform weekly psychometry and blood draws before and after ECT sessions one, seven, and twelve. The subsequent biopsychological analysis comprises omics, physiological, neurocognitive, and psychometric measurements. The multimodal data collected will be used to identify data-driven clusters associated with ECT mechanisms and outcome.

Conditions

Depressive Disorder; Bipolar Disorder

Keywords

electroconvulsive therapy; biomarkers; genetics; depression; prediction; molecular neuroscience

Outcome Measures

Primary Outcomes (16)

• Genetics

  Genotyping based on material extracted from peripheral blood

  baseline

• Changes in gene expression over time

  Longitudinal analysis of mRNA extracted from peripheral blood

  baseline, week 4, week 7

• Changes in epigenetics including gene methylation and miRNA expression over time

  Longitudinal analysis of DNA methylation and miRNA expression from peripheral blood

  baseline, week 4, week 7

• Protein, lipid, and electrolyte changes over time

  Longitudinal analysis of blood-based proteins (e.g. CRP, IL6), lipids (e.g. cholesterol), electrolytes, and other molecules from peripheral blood

  baseline, week 4, week 7

• Changes in immunophenotyping over time

  Longitudinal phenotyping of different immune cell populations from peripheral blood mononuclear cells (PBMCs)

  baseline, week 4, week 7

• Changes in purinergic signalling over time

  Longitudinal measurement of purines and pyrimidines as well as their metabolites in peripheral blood

  baseline, week 4, week 7

• Changes in body mass index (BMI) over time

  Longitudinal analysis of body mass index (BMI)

  baseline, week 4, week 7

• Changes in blood pressure over time

  Longitudinal analysis of blood pressure

  baseline, week 4, week 7

• Clinical and socioeconomic factors

  Influence on treatment response

  baseline

• Change from baseline in the Hamilton Depression Rating Scale (HAM-D)

  The HAM-D measures the presence and severity of depression. Each of the items is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the HAM-D score is ≤ 7 points

  Baseline, week 4, and week 7

• Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS)

  The MADRS measures the presence and severity of depression. Each of the terms is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the MADRS score falls short of 12 points

  Baseline, week 4, and week 7

• Change from baseline in the Global Assessment of Functioning (GAF)

  The GAF approximates the level of symptom burden and psychosocial as well as occupational functioning in daily life. It is tailored primarily to psychiatric patients. It is rated from 0 to 100 by a trained clinician. The GAF score is a continuous variable and allows to estimate symptom reduction and functional assessment from a foreign rater perspective

  Baseline, week 4, and week 7

• Change from baseline in the Beck-Depression-Inventory II (BDI-II)

  The BDI-II measures the presence and severity of depression symptoms on a mostly psychological and partially somatic level. Each of the 21 items is rated by the patient and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the BDI-II score is ≤ 10 points

  weekly

• Change from baseline in the Patient Health Questionnaire 9 (PHQ-9)

  The PHQ-9 is a brief measure of depression symptoms. Each of the 9 items is rated by the patient from 0 = not at all to 3 = nearly every day and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the PHQ-9 score is ≤ 5 points.

  weekly

• Change from baseline in the Patient Health Questionnaire 15 (PHQ-15)

  The PHQ-15 is a measure of somatic symptom load in psychiatric disorders. Each of the 15 somatic symptoms is rated by the patient from 0 = not affected to 2 = strongly affected and added up to a summary score. Cut-off values are ≥ 5points (mild), ≥ 10 points (moderate), ≥ 15 points (severe) and represent somatization

  weekly

• Change from baseline in the Questionnaire on Mental Capacity (FLEI = dt. Fragebogen zur geistigen Leistungsfähigkeit)

  The FLEI measures neurocognitive functioning in the following domains: attention, memory, executive function, control scale. Each of the 35 questions is answered by the patient from 0 = never to 4 = very often. Summary scores are computed for the different neurocognitive domains. Since the FLEI is primarily a continuous variable, symptom reduction is commonly assessed quantitively

  weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Only persons of legal age who are in inpatient psychiatric treatment at the Max Planck Institute for Psychiatry and have given consent to participate in local biobanking can take part in the present DetECT study.

You may qualify if:

• Age ≥ 18 years (of legal age, legally competent) and desire to participate
• Diagnosis of a depressive episode (also in the case of bipolar affective disorder) or depression according to the ICD-10 or ICD-11 or DSM-4 or DSM-5
• Indication and planned electroconvulsive therapy
• Signed Electroconvulsive Therapy Informed Consent Form
• Consent to participate by personally signing the declaration of consent including data protection concept and data use for the DetECT study
• Consent and participation in MPI of Psychiatry's biobanking

You may not qualify if:

• Age \< 18 years (minor)
• Pregnancy and breastfeeding
• Existence of legal supervision
• Pervasive developmental disorders and/or intellectual disability
• Acute, relevant substance abuse of alcohol, over-the-counter and prescription drugs, or illicit drugs
• Severe neurological disease (especially severe organic brain damage)
• Acute, serious general illness (especially clinically relevant, aplastic and/or anemia requiring transfusion)

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

RECRUITING

Related Publications (1)

• von Mucke-Heim IA, Pape JC, Grandi NC, Erhardt A, Deussing JM, Binder EB. Multiomics and blood-based biomarkers of electroconvulsive therapy in severe and treatment-resistant depression: study protocol of the DetECT study. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):673-684. doi: 10.1007/s00406-023-01647-1. Epub 2023 Aug 30.

  PMID: 37644215 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Elisabeth B Binder, MD, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julius Pape, MD, PhD

CONTACT

0049-89-30622; detect@psych.mpg.de

Iven von Mücke-Heim, MD, MSc

CONTACT

0049-89-30622; detect@psych.mpg.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 19, 2022
• Study Start: February 24, 2022
• Primary Completion: February 23, 2025
• Study Completion: February 23, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)