A Phase 4 interventional study of ECT Mecta 5000M and Methohexitone in Depression, sponsored by St Patrick's Hospital, Ireland. Completed at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by St Patrick's Hospital, Ireland · Phase 4, Interventional, and Treatment
Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and is often life-saving. There are concerns, however, that standard bitemporal ECT (the most commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT but have much less cognitive side-effects.
The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right unilateral ECT is as effective as (i.e. not inferior to) standard (1.5 x ST) bitemporal ECT for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the treatment course.
The study is a two-group parallel design randomised controlled non-inferiority trial and has been registered (ISRCTN23577151). Consented patients with major depressive disorder (DSM-IV) will be randomly allocated to a course of bitemporal (BT) ECT (1.5 x ST) or high-dose right unilateral (RUL) ECT (6.0 x ST). To facilitate generalizability of results, the trial takes place under "real world" conditions and so both groups continue usual care and medications during the treatment phase and thereafter. Patients are followed-up for 12 months after completing their allocated course of ECT. Completion of the primary outcome depression-rating measure (i.e. HDRS) and the secondary outcome of most interest (autobiographical memory, using the AMI-SF) will be prioritised in the data collection.
Patients, their treating clinicians and raters are blind to treatment; clinicians administering ECT are not involved in post randomisation assessments or formal data analysis. Success of blinding for patients and raters will be assessed after the second and final treatments. The trial statistician is also blinded to allocation status.
Sample size: In a large series (n = 253) of depressed patients, Petrides et al. (2001) found a mean (SD) reduction in 24-item HDRS of 25.6 (9.4) after treatment with bitemporalT ECT (1.5 x ST). We therefore estimate that 69 patients will be required per treatment group to have 80% power to demonstrate, using a one-sided equivalence t-test at 5% level, that mean reduction in 24-item HDRS achieved using high-dose RUL ECT is no more than 4 points (i.e. equivalent to 3 points on 17-item HDRS) less than that achieved using standard BT ECT, assuming a common within-group SD of change scores of 9.4 and equal expected group mean change scores.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 138 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →St Patrick's Hospital, Ireland is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Device: ECT Mecta 5000M · Drug: Methohexitone · Drug: Suxamethonium
High-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.
Device: ECT Mecta 5000M · Drug: Methohexitone · Drug: Suxamethonium
ECT is administered twice weekly with hand-held electrodes using the Mecta 5000M device following a standard stimulus dosing protocol. Seizure duration is measured by EEG monitoring. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0 mg/kg) as muscle relaxant. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
Also known as: electroconvulsive therapy Mecta 500M device
Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia along with suxamethonium (0.5-1.0 mg/kg)for muscle relaxation. Anesthesia is the same for both arms of the trial.
Also known as: methohexital, Brevimytal (Hikma, Germany)
Suxamethonium (0.5-1.0 mg/kg)is used for muscle relaxation along with Methohexitone (0.75-1.0 mg/kg) for anaesthesia. Anesthesia is the same for both arms of the trial.
Also known as: Succinylcholine, Anectine (GlaxoSmithKline, UK)
Hamilton Depression Rating Scale (HDRS)
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.
Time frame: HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints.
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
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..
Time frame: end of allocated ECT course
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
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..
Time frame: 3 months follow-up
Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
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..
Time frame: 6 months follow-up
| Milestone | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| Started | 69 | 69 |
| Completed | 69 | 67 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
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.
| units on a scale | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| Baseline | 29.5 ± 6.3 | 30.4 ± 6.1 |
| End-of-treatment | 12.5 ± 9.2 | 11.1 ± 7.5 |
| 3 months follow-up | 15.0 ± 10.2 | 11.5 ± 9.1 |
| 6 months follow-up | 13.0 ± 8.6 | 12.6 ± 10.9 |
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..
| % of baseline performance | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 56.8 ± 17.3 | 67.1 ± 16.3 |
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..
| % of baseline performance | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 56.2 ± 18.1 | 67.3 ± 14.2 |
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..
| % of baseline performance | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| Columbia Autobiographical Memory Interview-Short Form (AMI-SF) | 52.9 ± 16.4 | 63.4 ± 17.7 |
Collected over Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bilateral ECT Mecta 5000M | — | 9/69 (13%) | 33/69 (47.8%) |
| High-dose Unilateral ECT Mecta 5000M | — | 7/69 (10.1%) | 37/69 (53.6%) |
| Event | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| ECT-related hypertensionCardiac disorders | 2/69 | 4/69 |
| interictal confusionNervous system disorders | 3/69 | 0/69 |
| laryngospasmRespiratory, thoracic and mediastinal disorders | 0/69 | 1/69 |
| tachyarrhythmiaCardiac disorders | 1/69 | 1/69 |
| attempted suicidePsychiatric disorders | 0/69 | 1/69 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 1/69 | 0/69 |
| bradyarrhythmiaCardiac disorders | 1/69 | 0/69 |
| pulmonary embolusRespiratory, thoracic and mediastinal disorders | 1/69 | 0/69 |
| Event | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M |
|---|---|---|
| HeadacheNervous system disorders | 19/69 | 18/69 |
| nauseaGastrointestinal disorders | 8/69 | 11/69 |
| muscle painMusculoskeletal and connective tissue disorders | 6/69 | 8/69 |
| Age, Continuous(years) | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M | Total |
|---|---|---|---|
| Mean | 56.8 ± 14.4 | 56.6 ± 15.3 | 56.7 ± 14.8 |
| Sex: Female, Male(Participants) | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M | Total |
|---|---|---|---|
| Female | 47 | 40 | 87 |
| Male | 22 | 29 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 69 | 69 | 138 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bilateral ECT Mecta 5000M | High-dose Unilateral ECT Mecta 5000M | Total |
|---|---|---|---|
| Ireland | 69 | 69 | 138 |
Plan to share: Undecided — We are continuing to analyze trial data for secondary analyses. Requests for IPD will be considered where appropriate.
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Studies of the drugs tested here: Methohexital · Succinylcholine
St Patrick's Hospital, Ireland