Treatment Resistant DepressionPhase 2/3ELEKT-DNCT03113968

ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

A Phase 2/3 study testing electroconvulsive therapy (ECT) and Ketamine in people with Treatment Resistant Depression and Electroconvulsive Therapy, run by Bo Hu at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Treatment Resistant Depression, Electroconvulsive Therapy, ECT
What is being tested?: electroconvulsive therapy (ECT) and Ketamine
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 403 participants
Where: 5 sitesUnited States
Study dates: 7 Apr 2017to 17 Nov 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent before any study related procedures are performed
Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
Males/females at least 21 years of age but no older than 75 years of age
Meet DSM-5 criteria for Major Depressive Episode as determined by both:
a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
A current depressive episode that has lasted a minimum of 4 weeks

Show all 10Show fewer

Meet all of the following criteria on symptom rating scales at screening:
Montgomery Asberg Depression Rating Scale (MADRS) score >20 B. Young Mania Rating Scale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18
Have had ≥2 adequate trials of antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose. This will be equal to a trial rating of 3 or more.
In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study

Who cannot join

Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
The patient is pregnant or breast feeding
The patient has a severe medical illness or severe neurological disorder
The patient has a known ketamine allergy or is taking a medication that may interact with ketamine
Diagnosis of major depressive disorder with psychotic features during the current depressive episode
Unable to give informed consent
Was previously enrolled/randomized into the trial

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
Yale School of Medicine
New Haven, Connecticut, 06510
Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Read the detailed description

Patients with treatment resistant depression who meet all inclusion criteria and do not meet any exclusion criteria will be randomized to either electroconvulsive therapy (ECT) three times per week or ketamine infusion two times per week. Patients will answer questionnaires about their symptoms prior to treatments. The acute treatment phase of the study will last three to five weeks. Depending on response to treatment, some patients will be followed for an additional six months.

Conditions: Treatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression
Being tested: electroconvulsive therapy (ECT), Ketamine
Medical subject headings: Depressive Disorder, Treatment-Resistant, Mental Disorders, Depression, Depressive Disorder, Major, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

electroconvulsive therapy (ECT)Procedure or surgery
ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.
KetamineDrug
Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.

Study groups in NCT03113968
Study group	Role	What they receive
electroconvulsive therapy (ECT)	Active comparator	Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion. Receives: Procedure: electroconvulsive therapy (ECT)
ketamine infusion	Active comparator	Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion. Receives: Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)
Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.
Measured: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Secondary outcomes (1)

Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)
The outcome measure was the percentage of responders at the end-of-treatment visit, defined as a ≥50% decrease in MADRS score from the baseline visit (i.e., first treatment visit) to the end-of-treatment visit (within 3 days of last treatment).
Measured: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 201717 Nov 2022

First posted14 Apr 2017
Study start7 Apr 2017
Primary completion28 Oct 2022
Study completion17 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: unblinded prospective randomized open-label
Masking: None (open label)
Enrolment: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03113968
Sponsor's protocol ID: ELEKT-D
Acronym: ELEKT-D
Status last verified: Sep 2023
First submitted: 9 Feb 2017
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25.
PubMed 17640154
Kellner CH, Greenberg RM, Murrough JW, Bryson EO, Briggs MC, Pasculli RM. ECT in treatment-resistant depression. Am J Psychiatry. 2012 Dec;169(12):1238-44. doi: 10.1176/appi.ajp.2012.12050648.
PubMed 23212054
Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available.
PubMed 17989386
Newport DJ, Carpenter LL, McDonald WM, Potash JB, Tohen M, Nemeroff CB; APA Council of Research Task Force on Novel Biomarkers and Treatments. Ketamine and Other NMDA Antagonists: Early Clinical Trials and Possible Mechanisms in Depression. Am J Psychiatry. 2015 Oct;172(10):950-66. doi: 10.1176/appi.ajp.2015.15040465.
PubMed 26423481
Sanacora G, Heimer H, Hartman D, Mathew SJ, Frye M, Nemeroff C, Robinson Beale R. Balancing the Promise and Risks of Ketamine Treatment for Mood Disorders. Neuropsychopharmacology. 2017 May;42(6):1179-1181. doi: 10.1038/npp.2016.193. Epub 2016 Sep 19. No abstract available.
PubMed 27640324
Kumpf KT, Wilkinson ST, Hu B, Chen R, Krishnan K, Chakrabarti S, Rhee TG, Grezmak T, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Collins KA, Barnett BS, Anand A. Comparing the Cognitive Effects of Repeated Intravenous Ketamine and Electroconvulsive Therapy in Patients With Treatment-Resistant Depression: A Secondary Analysis of the ELEKT-D Trial. J Clin Psychiatry. 2025 Sep 3;86(4):25m15781. doi: 10.4088/JCP.25m15781.
PubMed 40900112
Anand A, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Altinay M, Aloysi AS, Asghar-Ali AA, Barnett BS, Chang LC, Collins KA, Costi S, Iqbal S, Jha MK, Krishnan K, Malone DA, Nikayin S, Nissen SE, Ostroff RB, Reti IM, Wilkinson ST, Wolski K, Hu B. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression. N Engl J Med. 2023 Jun 22;388(25):2315-2325. doi: 10.1056/NEJMoa2302399. Epub 2023 May 24.
PubMed 37224232
Mathew SJ, Wilkinson ST, Altinay M, Asghar-Ali A, Chang LC, Collins KA, Dale RM, Hu B, Krishnan K, Kellner CH, Malone DA, Murrough JW, Ostroff RB, Sanacora G, Shao M, Anand A. ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol. Contemp Clin Trials. 2019 Feb;77:19-26. doi: 10.1016/j.cct.2018.12.009. Epub 2018 Dec 17.
PubMed 30572160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
ClinicalTrials.gov ID: NCT03113968
Acronym / sponsor ID: ELEKT-D / ELEKT-D
Conditions: Treatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Bo HuUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 7 Apr 2017 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 17 Nov 2022 (actual)
First posted: 14 Apr 2017 (actual)
Results: Posted 9 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: unblinded prospective randomized open-label

Arm	Type	Receives
electroconvulsive therapy (ECT)	Active comparator	Procedure: electroconvulsive therapy (ECT)Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.
ketamine infusion	Active comparator	Drug: KetamineTreatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Written informed consent before any study related procedures are performed
Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
Males/females at least 21 years of age but no older than 75 years of age
Meet DSM-5 criteria for Major Depressive Episode as determined by both:
A current depressive episode that has lasted a minimum of 4 weeks

Key exclusion criteria (8 listed)

Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
The patient is pregnant or breast feeding
The patient has a severe medical illness or severe neurological disorder
The patient has a known ketamine allergy or is taking a medication that may interact with ketamine

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 therapy (ECT)ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.	Procedure or surgery	electroconvulsive therapy (ECT)
KetamineKetamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.	Drug	ketamine infusion

Primary outcome

Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)
Time frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks
Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.

1 secondary outcome

Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)
Time frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

Results and safety

Results posted to the registry on 9 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electroconvulsive Therapy (ECT)	203	172
Ketamine Infusion	200	196

Primary outcome: Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)

Time frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks. Count of participants. Unit: Participants

Measure	Electroconvulsive Therapy (ECT) n = 170	Ketamine Infusion n = 195
Value	70	108

Electroconvulsive Therapy (ECT) vs Ketamine Infusion: p <.001, The Farrington-Manning score test

Population analysed: Modified Intention-to-treat Population (i.e., participants with at least one treatment and at least one follow-up measurement)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Electroconvulsive Therapy (ECT)	4 of 170 (2.4%)	27 of 170 (15.9%)	0 of 170
Ketamine Infusion	5 of 195 (2.6%)	32 of 195 (16.4%)	0 of 195

Limitations and caveats (from the sponsor): Our trial has several limitations. ECT was started with right unilateral placement and was then switched to bilateral placement in the event of inadequate response. The open-label design of our trial could have influenced response. Maintenance treatment was not studied. Other limitations of our trial include a lack of placebo, the flexibility of treatment methods, and a follow-up period during which the patients received treatment as presc

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17640154Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25.
Background: PubMed 23212054Kellner CH, Greenberg RM, Murrough JW, Bryson EO, Briggs MC, Pasculli RM. ECT in treatment-resistant depression. Am J Psychiatry. 2012 Dec;169(12):1238-44. doi: 10.1176/appi.ajp.2012.12050648.
Background: PubMed 17989386Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available.
Background: PubMed 26423481Newport DJ, Carpenter LL, McDonald WM, Potash JB, Tohen M, Nemeroff CB; APA Council of Research Task Force on Novel Biomarkers and Treatments. Ketamine and Other NMDA Antagonists: Early Clinical Trials and Possible Mechanisms in Depression. Am J Psychiatry. 2015 Oct;172(10):950-66. doi: 10.1176/appi.ajp.2015.15040465.
Background: PubMed 27640324Sanacora G, Heimer H, Hartman D, Mathew SJ, Frye M, Nemeroff C, Robinson Beale R. Balancing the Promise and Risks of Ketamine Treatment for Mood Disorders. Neuropsychopharmacology. 2017 May;42(6):1179-1181. doi: 10.1038/npp.2016.193. Epub 2016 Sep 19. No abstract available.
Derived from this study: PubMed 40900112Kumpf KT, Wilkinson ST, Hu B, Chen R, Krishnan K, Chakrabarti S, Rhee TG, Grezmak T, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Collins KA, Barnett BS, Anand A. Comparing the Cognitive Effects of Repeated Intravenous Ketamine and Electroconvulsive Therapy in Patients With Treatment-Resistant Depression: A Secondary Analysis of the ELEKT-D Trial. J Clin Psychiatry. 2025 Sep 3;86(4):25m15781. doi: 10.4088/JCP.25m15781.
Derived from this study: PubMed 37224232Anand A, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Altinay M, Aloysi AS, Asghar-Ali AA, Barnett BS, Chang LC, Collins KA, Costi S, Iqbal S, Jha MK, Krishnan K, Malone DA, Nikayin S, Nissen SE, Ostroff RB, Reti IM, Wilkinson ST, Wolski K, Hu B. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression. N Engl J Med. 2023 Jun 22;388(25):2315-2325. doi: 10.1056/NEJMoa2302399. Epub 2023 May 24.
Derived from this study: PubMed 30572160Mathew SJ, Wilkinson ST, Altinay M, Asghar-Ali A, Chang LC, Collins KA, Dale RM, Hu B, Krishnan K, Kellner CH, Malone DA, Murrough JW, Ostroff RB, Sanacora G, Shao M, Anand A. ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol. Contemp Clin Trials. 2019 Feb;77:19-26. doi: 10.1016/j.cct.2018.12.009. Epub 2018 Dec 17.
Individual participant dataSharing planned: No

Related trials for Treatment Resistant Depression

Active, not recruitingPhase 1
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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.

Amit Anand, MD principal investigator

The Cleveland Clinic

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing electroconvulsive therapy (ECT) and Ketamine in people with Treatment Resistant Depression and Electroconvulsive Therapy, run by Bo Hu at 5 sites in United States.

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 10 inclusion and 8 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) (time frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03113968, which also lists 8 linked publications.

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 28 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.