Treatment Resistant DepressionPhase 3ETESNCT04924257
ECT vs. Esketamine
A Phase 3 study testing Esketamine nasal spray and Electroconvulsive therapy in people with Treatment Resistant Depression and Major Depressive Disorder, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide. Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder
- What is being tested?
- Esketamine nasal spray and Electroconvulsive therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jul 2021to Apr 2024
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V).
- MADRS score ≥ 25
- Pharmacologically treatment-resistant depressive episode [Stage ≥ II, defined by Thase \& Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)] (88).
- Age: 18 - 50 years
- Written informed consent
Who cannot join
- Participation in another interventional clinical trial
- Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy:
- Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines
- Contraindications to the conduction of MRI
- History of one or more of the following diagnoses (DSM-5):
- MDD, single or recurrent episode with psychotic features (296.24; 296.34)
Show all 15Show fewer
- past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x)
- neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x)
- schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x)
- neurocognitive disorders (290.x, 292.x, 294.x, 331.x).
- history of ECT (unsuccessful or successful)
- suicidal tendency requiring admission in a locked ward
- pregnancy or lactation period
- lack of anesthetic clearance for any other reason
- insufficient command of German language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide.
Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms.
Read more
To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI).
In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.
- Being tested
- Esketamine nasal spray, Electroconvulsive therapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine nasal sprayDrug
Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS <10).
Electroconvulsive therapyProcedure or surgery
Also called ECT
Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10).
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Esketamine | Experimental | Not described Receives: Drug: Esketamine nasal spray |
| ECT | Active comparator | Not described Receives: Procedure: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score
Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as >50% reduction in score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start28 Jul 2021
- Primary completionAug 2023 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: No eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924257
- Sponsor's protocol ID
- 1417/2020
- Acronym
- ETES
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
- ClinicalTrials.gov ID
- NCT04924257
- Acronym / sponsor ID
- ETES / 1417/2020
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No eligible participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Jun 2021 (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.
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide.
Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms.
To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI).
In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Esketamine | Experimental | Drug: Esketamine nasal spray |
| ECT | Active comparator | Procedure: Electroconvulsive therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V).
- MADRS score ≥ 25
- Pharmacologically treatment-resistant depressive episode [Stage ≥ II, defined by Thase \& Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)] (88).
- Age: 18 - 50 years
- Written informed consent
Key exclusion criteria (15 listed)
- Participation in another interventional clinical trial
- Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy:
- Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines
- Contraindications to the conduction of MRI
- History of one or more of the following diagnoses (DSM-5):
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 |
|---|---|---|
| Esketamine nasal sprayPatients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS <10). | Drug | Intranasal Esketamine |
| Electroconvulsive therapyAlso: ECTPatients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10). | Procedure or surgery | ECT |
Primary outcome
MADRS score
Time frame: 4 weeks
Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as >50% reduction in score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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?
A Phase 3 study testing Esketamine nasal spray and Electroconvulsive therapy in people with Treatment Resistant Depression and Major Depressive Disorder, run by Medical University Innsbruck 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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 5 Aug 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
MADRS score (time frame: 4 weeks). 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 5 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.