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NCT Number: NCT05630469

Prediction of Antidepressant Effects of Electroconvulsive Therapy

Despite its successful use for more than 80 years, the mechanisms of action of electroconvulsive therapy (ECT) are still not fully understood. ECT has been shown to be accompanied by changes in regional brain volumes and connectivity measures, as well as biochemical alterations. However, how these changes relate to ECT response remains to be further elucidated; up to now, there are no objective markers for the targeted use of ECT in clinical practice.

Methods: Study design: longitudinal mono-centre study with duration of 36 months. Subjects: 30 depressed patients (aged 18-65 years) eligible for ECT. Measurements: subjects will undergo 2 3-Tesla MRI scans (one before and one after a course of ECT), including structural MRI, resting-state functional MRI, task-based functional MRI and MR spectroscopy. Blood, CSF sampling and clinical assessments will be performed once before and once after the ECT course. ECT: Each patient will be treated in a min. of 8 bitemporal ECT sessions (~4 weeks). Data analysis: Longitudinal changes in brain imaging parameters and laboratory measures (before/after ECT) will be assessed using repeated-measures analysis of covariance. Machine learning with random forests will be employed to identify a pattern of pretreatment imaging, biochemical (serum and CSF) and clinical parameters that are best qualified to predict response to ECT as defined by a reduction of ≥50% of baseline HAMD17.

Hypotheses: 1. ECT will be accompanied by changes in brain morphology, functional connectivity, neuronal activation in response to cognitive and reward-related stimuli and neurochemical signals in the brain. 2. ECT leads to changes in blood- and CSF-based markers of neuronal plasticity, neurodegeneration and inflammation, as well as genetic/epigenetic markers. 3. Predictive markers of ECT response can be established based on the relationships between imaging, neurochemical and clinical markers and treatment response.

Innovation: This study would be the first to combine multimodal MRI measures with the assessment of biomarkers in the CSF in the context of ECT. The implementation of the proposed trial represents an important step towards a better understanding of the powerful antidepressant properties of ECT. By relating treatment effects and potentially underlying biological mechanisms on numerous complementary levels, the study might help to identify biomarkers that distinguish patients who are likely to benefit from ECT from non-responders. Ultimately, results of the study might be useful in order to establish an individualized medical indication for ECT.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Pia Baldinger-Melich, MD, PhD, PD, Assoc. Prof.

CONTACT

[email protected]

+43 1 4040035350

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female inpatients (18-65 years old)
  • ICD-10 diagnosis of severe unipolar depression (F32.2, F32.3, F33.2, F33.3)
  • HAMD17 ≥ 23
  • physical health
  • ability to understand and willingness to sign the written informed consent document
  • negative drug screening, negative urine pregnancy test in women
  • antidepressant and antipsychotic medication in steady state for at least 10 days prior inclusion
  • anesthesiological approval for ECT

Excusion criteria:

  • severe somatic or neurological disease
  • current comorbid psychiatric disorder, including bipolar depression (according to DSM-5)
  • current or past history of schizophrenia or schizoaffective disorder
  • current use of alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-5 criteria for alcohol or other substance dependence
  • clinically relevant abnormalities on a general physical examination and routine laboratory screening
  • pregnancy, breast feeding
  • contraindications to lumbar puncture (increased intracranial volume, anticoagulant medication, uncorrected bleeding diathesis, coagulopathy, congenital spine abnormality, recent spinal trauma/surgery, skin infection at puncture site)
  • any implant or stainless steel graft contraindicated for MRI

Treatment and study plan

Electroconvulsive therapy

Other

repetitive induction of a generalized seizure under controlled conditions (muscle relaxation and sedation)

Primary outcomes

  1. imaging parameter - sMRI

    Time frame: 3 years

    cortical thickness

  2. imaging parameters - DTI

    Time frame: 3 years

    mean diffusivity

  3. imaging parameters - fMRI

    Time frame: 3 years

    BOLD activity (task-based fMRI for cognition and anhedonia)

  4. imaging parameters - rsfMRI

    Time frame: 3 years

    BOLD activity (rsfMRI)

  5. imaging parameters - MRS

    Time frame: 3 years

    Glx, NAA and GABA concentrations (MRS)

  6. biochemical parameters - neurodegeneration

    Time frame: 3 years

    concentrations of markers of neurodegeneration serum and CSF

  7. biochemical parameters - inflammation

    Time frame: 3 years

    concentrations of markers of neuroinflammation serum and CSF

  8. biochemical parameters - neurplasticity

    Time frame: 3 years

    concentrations of markers of neuroplasticity serum and CSF

  9. response prediction

    Time frame: 3 years

    machine learning - how do outcome 1 and 2 relate to response to ECT

Study contacts

Contact information is provided by the study sponsor or research team.

Pia Baldinger-Melich, MD, PhD, PD, Assoc.Prof.

CONTACT

[email protected]

+43 1 40400 35350

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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