Depressive Disorder, MajorNCT05630469
Prediction of Antidepressant Effects of Electroconvulsive Therapy
An observational study of Depressive Disorder, Major, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Electroconvulsive therapy
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2022to 31 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with a major depressive episode (unipolar depression) as determined by a structured clinical interview for DSM-5 (SCID-5-clinical version) and the 17-item Hamilton rating scale for depression (HAM-D score ≥ 23) who did not respond to conventional pharmacological antidepressant treatment and are eligible for ECT will be recruited at the Department of Psychiatry and Psychotherapy at the General Hospital of Vienna.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, 1090
About this study
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.
Read more
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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Electroconvulsive therapy
- Keywords
- electroconvulsive therapy, neuroimaging, response prediction, biomarker
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyOther
repetitive induction of a generalized seizure under controlled conditions (muscle relaxation and sedation)
| Study group | Role | What they receive |
|---|---|---|
| Depression | Depressive patients (pharmaco-resistant) undergoing electroconvulsive therapy Receives: Other: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
imaging parameter - sMRI
cortical thickness
Measured: 3 years
imaging parameters - DTI
mean diffusivity
Measured: 3 years
imaging parameters - fMRI
BOLD activity (task-based fMRI for cognition and anhedonia)
Measured: 3 years
imaging parameters - rsfMRI
BOLD activity (rsfMRI)
Measured: 3 years
imaging parameters - MRS
Glx, NAA and GABA concentrations (MRS)
Measured: 3 years
biochemical parameters - neurodegeneration
concentrations of markers of neurodegeneration serum and CSF
Measured: 3 years
biochemical parameters - inflammation
concentrations of markers of neuroinflammation serum and CSF
Measured: 3 years
biochemical parameters - neurplasticity
concentrations of markers of neuroplasticity serum and CSF
Measured: 3 years
response prediction
machine learning - how do outcome 1 and 2 relate to response to ECT
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Dec 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Baldinger-Melich, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630469
- Sponsor's protocol ID
- KLI 1098-B
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Antidepressant Effects of Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05630469
- Acronym / sponsor ID
- KLI 1098-B
- Conditions
- Depressive Disorder, Major
- Keywords
- electroconvulsive therapy, neuroimaging, response prediction, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depression | – | Other: Electroconvulsive therapyDepressive patients (pharmaco-resistant) undergoing electroconvulsive therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with a major depressive episode (unipolar depression) as determined by a structured clinical interview for DSM-5 (SCID-5-clinical version) and the 17-item Hamilton rating scale for depression (HAM-D score ≥ 23) who did not respond to conventional pharmacological antidepressant treatment and are eligible for ECT will be recruited at the Department of Psychiatry and Psychotherapy at the General Hospital of Vienna.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapyrepetitive induction of a generalized seizure under controlled conditions (muscle relaxation and sedation) | Other | Depression |
Primary outcome
imaging parameter - sMRI
Time frame: 3 years
cortical thickness
imaging parameters - DTI
Time frame: 3 years
mean diffusivity
imaging parameters - fMRI
Time frame: 3 years
BOLD activity (task-based fMRI for cognition and anhedonia)
imaging parameters - rsfMRI
Time frame: 3 years
BOLD activity (rsfMRI)
imaging parameters - MRS
Time frame: 3 years
Glx, NAA and GABA concentrations (MRS)
biochemical parameters - neurodegeneration
Time frame: 3 years
concentrations of markers of neurodegeneration serum and CSF
biochemical parameters - inflammation
Time frame: 3 years
concentrations of markers of neuroinflammation serum and CSF
biochemical parameters - neurplasticity
Time frame: 3 years
concentrations of markers of neuroplasticity serum and CSF
response prediction
Time frame: 3 years
machine learning - how do outcome 1 and 2 relate to response to ECT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Medical University of Vienna at 1 site in Austria.
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 17 inclusion and 0 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 9 Oct 2026. 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 Austria. 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?
imaging parameter - sMRI (time frame: 3 years). The study lists 9 primary outcomes in all. 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 9 Oct 2026.