Trial · NCT01881763
Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression
NCT01881763, Phase 4, Completed, Northwell Health; results first posted 2023-03-09
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression. Trials, record NCT01881763. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01881763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression
- NCT number
- NCT01881763
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 31 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Unipolar Depression, Bipolar Depression
- Interventions
- Ketamine, Methohexital
- First posted
- 2013-06-20
- Last updated
- 2023-03-09
- Results first posted
- 2023-03-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (HRSD) Improvement | Days required to achieve remission (on average 3-4 weeks) | The items mostly range from a score of 0-4 but there are some questions that range from a score of 0-2. The maximum total score that can be reported is 76 and the lowest score is 0. Higher values represent a worse outcome. Items are summed together to compute the total score. Remission is defined as two consecutive Hamilton Rating Scale for Depression, 24 items (HRSD-24) scores \< 10, and HRSD-24 total score does not increase \> 3 points on the second consecutive HRSD-24, or remains \< 6 at the last two consecutive treatments. HRSD-24 scores are used to define remission. |
| Secondary | Cognitive Side Effects of ECT | Neuropsychological Battery: Changes from baseline to the end of the ECT course (on average 3-4 weeks) | To determine the cognitive side effects we will use the following neuropsychological battery: * Mini- Mental State Examination (MMSE), * Postictal Recovery of Orientation, * Rey Auditory Verbal Learning Test (RAVLT) * Autobiographical Memory Interview - Short Form (AMI - SF), * Subjective Memory Questionnaire (SMQ), * Reading subtest of the Wide Range Achievement Test, 3rd Edition (WRAT-3), * The Stroop Color Word Test (SCWT) (Golden version), * Trail Making Test Part A \& B, * Wechsler Adult Intelligence Test-Third Edition (WAIS-III), Digit Span Subtest, * WAIS-III Digit Symbol, * Controlled Oral Word Association Test (COWAT), * N-Back test |
| Other | Resting Stated Functional Magnetic Resonance Imaging (rs fMRI) | Changes from baseline to the end of ECT course (approximately 3-4 weeks) | To use resting state and task related fMRI to identify ECT related functional network changes in the brain. Using resting state fMRI before and after ECT, we will (a) identify networks modulated by ECT (defined as a decrease or increase in functional connectivity from baseline to follow up scans), and we will (b) follow up their expression in the upcoming weeks, we will (c) identify functional networks of the brain which are correlated with superior clinical ECT outcome and we will (d) identify functional networks of the brain which are correlated with side effect profiles. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hamilton Rating Scale for Depression (HRSD) Improvement | Days required to achieve remission (on average 3-4 weeks) | HRSD units | MEAN | |
| SECONDARY | Cognitive Side Effects of ECT | Neuropsychological Battery: Changes from baseline to the end of the ECT course (on average 3-4 weeks) | Data was not collected and the outcome cannot be reported. A total of 0 participants were analyzed due to slower than anticipated recruitment for this study therefore, we were not able to recruit a sufficient number of subjects for statistical analysis prior to the end of the funding period. | ||
| OTHER_PRE_SPECIFIED | Resting Stated Functional Magnetic Resonance Imaging (rs fMRI) | Changes from baseline to the end of ECT course (approximately 3-4 weeks) | Data was not collected and the outcome cannot be reported. A total of 0 participants were analyzed due to slower than anticipated recruitment for this study therefore, we were not able to recruit a sufficient number of subjects for statistical analysis prior to the end of the funding period. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hamilton Rating Scale for Depression (HRSD) Improvement | Ketamine | 7.82 | Standard Deviation 3.43 | HRSD units | |
| Hamilton Rating Scale for Depression (HRSD) Improvement | Methohexital | 8.60 | Standard Deviation 3.72 | HRSD units |
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 | Ketamine | 16 | |
| Overall Study | STARTED | Methohexital | 15 | |
| Overall Study | COMPLETED | Ketamine | 10 | |
| Overall Study | COMPLETED | Methohexital | 11 | |
| Overall Study | NOT COMPLETED | Ketamine | 6 | |
| Overall Study | NOT COMPLETED | Methohexital | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine | 0 | 16 |
| Total, all-cause mortality | Methohexital | 0 | 15 |
| Total, other adverse events | Ketamine | 0 | 16 |
| Total, other adverse events | Methohexital | 0 | 15 |
| Total, serious adverse events | Ketamine | 0 | 16 |
| Total, serious adverse events | Methohexital | 0 | 15 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketamine vs Methohexital: deaths from any cause | Trial comparisons |
| Ketamine vs Methohexital: serious adverse events | Trial comparisons |
Tests7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT01881763
GET https://conductscience.org/api/trials/v1/NCT01881763/registered