Trial · NCT03113968
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
NCT03113968, Phase 2, Phase 3, Completed, Bo Hu; results first posted 2023-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD). Trials, record NCT03113968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03113968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
- NCT number
- NCT03113968
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 403 participants, actual
- Lead sponsor
- Bo Hu
- Conditions
- Treatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression, Major Depressive Disorder, Major Depressive Episode, Unipolar Depression
- Interventions
- electroconvulsive therapy (ECT), Ketamine
- First posted
- 2017-04-14
- Last updated
- 2023-09-28
- Results first posted
- 2023-08-09
- Limitations and caveats
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
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | 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. |
| Secondary | Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks | Modified Intention-to-treat Population (i.e., participants with at least one treatment and at least one follow-up measurement) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks | Modified intention-to-treat population (i.e., participants with at least one treatment and at least one follow-up measurement). One participant in the ECT group had missing baseline MADRS and was further excluded. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | Electroconvulsive Therapy (ECT) | 70 | Participants | ||
| Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | Ketamine Infusion | 108 | Participants | ||
| Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | Electroconvulsive Therapy (ECT) | 70 | Participants | ||
| Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | Ketamine Infusion | 99 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Electroconvulsive Therapy (ECT) | 203 | |
| Overall Study | STARTED | Ketamine Infusion | 200 | |
| Overall Study | COMPLETED | Electroconvulsive Therapy (ECT) | 172 | |
| Overall Study | COMPLETED | Ketamine Infusion | 196 | |
| Overall Study | NOT COMPLETED | Electroconvulsive Therapy (ECT) | 31 | |
| Overall Study | NOT COMPLETED | Ketamine Infusion | 4 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Electroconvulsive Therapy (ECT) | 12 | 170 | |
| other | Headache | General disorders | Ketamine Infusion | 16 | 195 | |
| other | Hypertension (severe / prolonged) | Cardiac disorders | Electroconvulsive Therapy (ECT) | 4 | 170 | |
| other | Hypertension (severe / prolonged) | Cardiac disorders | Ketamine Infusion | 6 | 195 | |
| other | Muscle Pain / Weakness | Musculoskeletal and connective tissue disorders | Electroconvulsive Therapy (ECT) | 9 | 170 | |
| other | Muscle Pain / Weakness | Musculoskeletal and connective tissue disorders | Ketamine Infusion | 1 | 195 | |
| other | Nausea | Gastrointestinal disorders | Electroconvulsive Therapy (ECT) | 6 | 170 | |
| other | Nausea | Gastrointestinal disorders | Ketamine Infusion | 10 | 195 | |
| other | Non-Cardiac Jaw Pain | Musculoskeletal and connective tissue disorders | Electroconvulsive Therapy (ECT) | 4 | 170 | |
| other | Non-Cardiac Jaw Pain | Musculoskeletal and connective tissue disorders | Ketamine Infusion | 0 | 195 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Electroconvulsive Therapy (ECT) | 0 | 170 |
| Total, all-cause mortality | Ketamine Infusion | 0 | 195 |
| Total, other adverse events | Electroconvulsive Therapy (ECT) | 27 | 170 |
| Total, other adverse events | Ketamine Infusion | 32 | 195 |
| Total, serious adverse events | Electroconvulsive Therapy (ECT) | 4 | 170 |
| Total, serious adverse events | Ketamine Infusion | 5 | 195 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Electroconvulsive Therapy (ECT) vs Ketamine Infusion: Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | Trial comparisons |
| Electroconvulsive Therapy (ECT) vs Ketamine Infusion: Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | Trial comparisons |
| Electroconvulsive Therapy (ECT) vs Ketamine Infusion: deaths from any cause | Trial comparisons |
| Electroconvulsive Therapy (ECT) vs Ketamine Infusion: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03113968
GET https://conductscience.org/api/trials/v1/NCT03113968/events?page=2