Trial · NCT01907217
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
NCT01907217, Phase 4, Completed, St Patrick's Hospital, Ireland; results first posted 2018-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression. Trials, record NCT01907217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01907217
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
- NCT number
- NCT01907217
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 138 participants, actual
- Lead sponsor
- St Patrick's Hospital, Ireland
- Conditions
- Depression
- Interventions
- ECT Mecta 5000M, Methohexitone, Suxamethonium
- First posted
- 2013-07-24
- Last updated
- 2018-11-14
- Other registries' IDs
- isrctn:ISRCTN23577151
- Results first posted
- 2018-11-14
- Limitations and caveats
We did not include involuntary patients who could not consent due to illness severity (7.4% of referrals), for whom bitemporal ECT may be better. The AMI-SF does not allow quantification of retrograde amnesia attributable directly to ECT.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HDRS) | HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints. | The HDRS was originally designed to assess severity of depressive symptoms in patients with a primary depressive illness and is now the most commonly used measure of depression severity. It was first published in a 17-item format with the optional addition of 4 items making up the 21-item version. In addition to the original 21 items, the 24-item HDRS includes items on helplessness, hopelessness and worthlessness; its score range is 0-77, with higher scores reflecting greater burden of depressive symptoms. |
| Secondary | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | end of allocated ECT course | The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance.. |
| Secondary | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 3 months follow-up | The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance.. |
| Secondary | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 6 months follow-up | The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance.. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hamilton Depression Rating Scale (HDRS) | HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints. | Intention to treat analysis. | units on a scale | MEAN |
| SECONDARY | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | end of allocated ECT course | Not all patients completed this cognitive task. | % of baseline performance | MEAN |
| SECONDARY | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 3 months follow-up | Not all patients completed this cognitive task. | % of baseline performance | MEAN |
| SECONDARY | Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 6 months follow-up | Not all patients completed this cognitive task. | % of baseline performance | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | Bilateral ECT Mecta 5000M | Baseline | 29.5 | Standard Deviation 6.3 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | High-dose Unilateral ECT Mecta 5000M | Baseline | 30.4 | Standard Deviation 6.1 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Bilateral ECT Mecta 5000M | End-of-treatment | 12.5 | Standard Deviation 9.2 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | High-dose Unilateral ECT Mecta 5000M | End-of-treatment | 11.1 | Standard Deviation 7.5 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Bilateral ECT Mecta 5000M | 3 months follow-up | 15.0 | Standard Deviation 10.2 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | High-dose Unilateral ECT Mecta 5000M | 3 months follow-up | 11.5 | Standard Deviation 9.1 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Bilateral ECT Mecta 5000M | 6 months follow-up | 13.0 | Standard Deviation 8.6 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | High-dose Unilateral ECT Mecta 5000M | 6 months follow-up | 12.6 | Standard Deviation 10.9 | units on a scale |
| Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | Bilateral ECT Mecta 5000M | 56.8 | Standard Deviation 17.3 | % of baseline performance | |
| Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | High-dose Unilateral ECT Mecta 5000M | 67.1 | Standard Deviation 16.3 | % of baseline performance |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bilateral ECT Mecta 5000M | 69 | |
| Overall Study | STARTED | High-dose Unilateral ECT Mecta 5000M | 69 | |
| Overall Study | COMPLETED | Bilateral ECT Mecta 5000M | 69 | |
| Overall Study | COMPLETED | High-dose Unilateral ECT Mecta 5000M | 67 | |
| Overall Study | NOT COMPLETED | Bilateral ECT Mecta 5000M | 0 | |
| Overall Study | NOT COMPLETED | High-dose Unilateral ECT Mecta 5000M | 2 |
Source ClinicalTrials.gov
Adverse events22
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 | Nervous system disorders | Bilateral ECT Mecta 5000M | 19 | 69 | 19 |
| other | Headache | Nervous system disorders | High-dose Unilateral ECT Mecta 5000M | 18 | 69 | 18 |
| other | nausea | Gastrointestinal disorders | Bilateral ECT Mecta 5000M | 8 | 69 | 8 |
| other | nausea | Gastrointestinal disorders | High-dose Unilateral ECT Mecta 5000M | 11 | 69 | 11 |
| other | muscle pain | Musculoskeletal and connective tissue disorders | Bilateral ECT Mecta 5000M | 6 | 69 | 6 |
| other | muscle pain | Musculoskeletal and connective tissue disorders | High-dose Unilateral ECT Mecta 5000M | 8 | 69 | 8 |
| serious | ECT-related hypertension | Cardiac disorders | Bilateral ECT Mecta 5000M | 2 | 69 | 2 |
| serious | ECT-related hypertension | Cardiac disorders | High-dose Unilateral ECT Mecta 5000M | 4 | 69 | 4 |
| serious | laryngospasm | Respiratory, thoracic and mediastinal disorders | Bilateral ECT Mecta 5000M | 0 | 69 | 0 |
| serious | laryngospasm | Respiratory, thoracic and mediastinal disorders | High-dose Unilateral ECT Mecta 5000M | 1 | 69 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bilateral ECT Mecta 5000M | ||
| Total, all-cause mortality | High-dose Unilateral ECT Mecta 5000M | ||
| Total, other adverse events | Bilateral ECT Mecta 5000M | 33 | 69 |
| Total, other adverse events | High-dose Unilateral ECT Mecta 5000M | 37 | 69 |
| Total, serious adverse events | Bilateral ECT Mecta 5000M | 9 | 69 |
| Total, serious adverse events | High-dose Unilateral ECT Mecta 5000M | 7 | 69 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34752484 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bilateral ECT Mecta 5000M vs High-dose Unilateral ECT Mecta 5000M: serious adverse events |
Source 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/NCT01907217
GET https://conductscience.org/api/trials/v1/NCT01907217/events?page=2