Major Depressive DisorderPhase 4NCT02999269
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
A Phase 4 study testing MECTA Spectrum 5000Q Amplitude in people with Major Depressive Disorder, run by University of New Mexico at 1 site in United States.
Trial summary
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- MECTA Spectrum 5000Q Amplitude
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 23 Mar 2020
- Phase
- Phase 4
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder (with or without psychotic features)
- the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response
- Hamilton Depression Rating Scale 24-item (HDRS-24) > 21
- age range between 50 and 80 years of age
- right-handedness
Who cannot join
- Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)
- other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).
Read the detailed description
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes remit, and formerly suicidal or psychotically depressed patients will resume their premorbid levels of functioning. Independent of the antidepressant effect of ECT, many patients experience debilitating but transient cognitive effects such as attention and memory deficits. These unwanted side effects are particularly troubling for older patients who are more likely to have existing cognitive deficits. Both the stimulus delivery (electrode placement, pulse amplitude, and pulse width) and seizure induction appear to work in synergy, but the underlying mechanism of action for successful response has yet to be fully elucidated. Moreover, further work is needed to understand the relationship between clinical improvement and cognitive impairment. This investigation will examine the clinical and neurocognitive impact of targeted medial temporal lobe engagement as a function of pulse amplitude, one of several variable factors influencing the ECT charge. The ECT charge is measured in millicoulombs (mC) and derived from multiplying pulse train duration, pulse-pair frequency, pulse width, and pulse amplitude. Pulse amplitude determines the induced electric field strength in the brain and is presently fixed at 900 milliamperes (mA) with no clinical or scientific justification. The central hypothesis of this investigation is that the optimal pulse amplitude for an individual patient will enhance neuroplasticity (clinical response) while minimizing the disruption of dominant hemisphere hippocampal cognitive circuitry (resulting in cognitive stability). The preliminary data informs the dosage range between 600 and 800 mA. Pulse amplitudes outside of this range compromise efficacy (500 mA) or may increase risk of cognitive impairment (900 mA). The first aim of this investigation will identify the electric field strength and neuroplasticity associated with clinical response. Critically, this aim will establish the neuroplasticity threshold, which is defined as the electric field strength necessary to induce neuroplasticity. The second aim will detect the neural correlates of ECT-mediated cognitive changes, which may be related to disrupted dominant hemisphere long-term potentiation. The third aim will use data-driven dual regression to predict the optimal pulse amplitude for an individual patient. This contribution will be significant because the electric field, when manipulated by pulse amplitude, can subsequently maximize hippocampal neuroplasticity (efficacy) and minimize disrupted connectivity (cognitive stability) thus improving clinical outcomes.
- Conditions
- Major Depressive Disorder
- Being tested
- MECTA Spectrum 5000Q Amplitude
- Keywords
- electroconvulsive therapy, MRI, major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MECTA Spectrum 5000Q AmplitudeDevice
Current
| Study group | Role | What they receive |
|---|---|---|
| 600 mA Right Unilateral ECT | Experimental | MECTA Spectrum 5000Q Amplitude Receives: Device: MECTA Spectrum 5000Q Amplitude |
| 700 mA Right Unilateral ECT | Experimental | MECTA Spectrum 5000Q Amplitude Receives: Device: MECTA Spectrum 5000Q Amplitude |
| 800 mA Right Unilateral ECT | Active comparator | MECTA Spectrum 5000Q Amplitude Receives: Device: MECTA Spectrum 5000Q Amplitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity
Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)
Measured: post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.
Cognition
Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)
Measured: post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
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 (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Mind Research Network, University of Texas, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Christopher Abbott, University of New Mexico
- Investigators
- Chris Abbott, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999269
- Sponsor's protocol ID
- 5U01MH111826
- Other IDs
- 5U01MH111826
- Status last verified
- Jun 2023
- First submitted
- 16 Aug 2016
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: National Data Archive (NDA)
Publications
Abbott CC, Quinn D, Miller J, Ye E, Iqbal S, Lloyd M, Jones TR, Upston J, Deng Z, Erhardt E, McClintock SM. Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Am J Geriatr Psychiatry. 2021 Feb;29(2):166-178. doi: 10.1016/j.jagp.2020.06.008. Epub 2020 Jun 17.
PubMed 32651051Qi S, Calhoun VD, Zhang D, Miller J, Deng ZD, Narr KL, Sheline Y, McClintock SM, Jiang R, Yang X, Upston J, Jones T, Sui J, Abbott CC. Links between electroconvulsive therapy responsive and cognitive impairment multimodal brain networks in late-life major depressive disorder. BMC Med. 2022 Dec 8;20(1):477. doi: 10.1186/s12916-022-02678-6.
PubMed 36482369
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECT Pulse Amplitude and Medial Temporal Lobe Engagement
- ClinicalTrials.gov ID
- NCT02999269
- Acronym / sponsor ID
- 5U01MH111826
- Conditions
- Major Depressive Disorder
- Keywords
- electroconvulsive therapy, MRI, major depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Mind Research Network, University of Texas, National Institute of Mental Health (NIMH)
- Study start
- Oct 2016
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 24 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).
Detailed description
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes remit, and formerly suicidal or psychotically depressed patients will resume their premorbid levels of functioning. Independent of the antidepressant effect of ECT, many patients experience debilitating but transient cognitive effects such as attention and memory deficits. These unwanted side effects are particularly troubling for older patients who are more likely to have existing cognitive deficits. Both the stimulus delivery (electrode placement, pulse amplitude, and pulse width) and seizure induction appear to work in synergy, but the underlying mechanism of action for successful response has yet to be fully elucidated. Moreover, further work is needed to understand the relationship between clinical improvement and cognitive impairment. This investigation will examine the clinical and neurocognitive impact of targeted medial temporal lobe engagement as a function of pulse amplitude, one of several variable factors influencing the ECT charge. The ECT charge is measured in millicoulombs (mC) and derived from multiplying pulse train duration, pulse-pair frequency, pulse width, and pulse amplitude. Pulse amplitude determines the induced electric field strength in the brain and is presently fixed at 900 milliamperes (mA) with no clinical or scientific justification. The central hypothesis of this investigation is that the optimal pulse amplitude for an individual patient will enhance neuroplasticity (clinical response) while minimizing the disruption of dominant hemisphere hippocampal cognitive circuitry (resulting in cognitive stability). The preliminary data informs the dosage range between 600 and 800 mA. Pulse amplitudes outside of this range compromise efficacy (500 mA) or may increase risk of cognitive impairment (900 mA). The first aim of this investigation will identify the electric field strength and neuroplasticity associated with clinical response. Critically, this aim will establish the neuroplasticity threshold, which is defined as the electric field strength necessary to induce neuroplasticity. The second aim will detect the neural correlates of ECT-mediated cognitive changes, which may be related to disrupted dominant hemisphere long-term potentiation. The third aim will use data-driven dual regression to predict the optimal pulse amplitude for an individual patient. This contribution will be significant because the electric field, when manipulated by pulse amplitude, can subsequently maximize hippocampal neuroplasticity (efficacy) and minimize disrupted connectivity (cognitive stability) thus improving clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.
| Arm | Type | Receives |
|---|---|---|
| 600 mA Right Unilateral ECT | Experimental | Device: MECTA Spectrum 5000Q AmplitudeMECTA Spectrum 5000Q Amplitude |
| 700 mA Right Unilateral ECT | Experimental | Device: MECTA Spectrum 5000Q AmplitudeMECTA Spectrum 5000Q Amplitude |
| 800 mA Right Unilateral ECT | Active comparator | Device: MECTA Spectrum 5000Q AmplitudeMECTA Spectrum 5000Q Amplitude |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of major depressive disorder (with or without psychotic features)
- the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response
- Hamilton Depression Rating Scale 24-item (HDRS-24) > 21
- age range between 50 and 80 years of age
- right-handedness
Key exclusion criteria (3 listed)
- Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)
- other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI.
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 |
|---|---|---|
| MECTA Spectrum 5000Q AmplitudeCurrent | Device | 600 mA Right Unilateral ECT, 700 mA Right Unilateral ECT, 800 mA Right Unilateral ECT |
Primary outcome
Depression Severity
Time frame: post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.
Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)
Cognition
Time frame: post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.
Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32651051Abbott CC, Quinn D, Miller J, Ye E, Iqbal S, Lloyd M, Jones TR, Upston J, Deng Z, Erhardt E, McClintock SM. Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Am J Geriatr Psychiatry. 2021 Feb;29(2):166-178. doi: 10.1016/j.jagp.2020.06.008. Epub 2020 Jun 17.
- Derived from this study: PubMed 36482369Qi S, Calhoun VD, Zhang D, Miller J, Deng ZD, Narr KL, Sheline Y, McClintock SM, Jiang R, Yang X, Upston J, Jones T, Sui J, Abbott CC. Links between electroconvulsive therapy responsive and cognitive impairment multimodal brain networks in late-life major depressive disorder. BMC Med. 2022 Dec 8;20(1):477. doi: 10.1186/s12916-022-02678-6.
- Individual participant dataSharing planned: Yes. National Data Archive (NDA)
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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.
Chris Abbott, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MECTA Spectrum 5000Q Amplitude in people with Major Depressive Disorder, run by University of New Mexico at 1 site 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 5 inclusion and 3 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Jul 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?
Depression Severity (time frame: post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.). The study lists 2 primary outcomes in all. 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 NCT02999269, which also lists 2 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 24 Jul 2023.