DepressionNCT05699226
Amplitude Titration to Improve ECT Clinical Outcomes
A study testing Soterix Medical Incorporated 4x1 adapter and Traditional ECT device in people with Depression and ECT, run by University of New Mexico at 1 site in United States.
Trial summary
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, ECT, Cognitive Change
- What is being tested?
- Soterix Medical Incorporated 4x1 adapter and Traditional ECT device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder or bipolar II
- Clinical indications for ECT with right unilateral electrode placement
Who cannot join
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
- Other psychiatric conditions (e.g., schizophrenia, bipolar I disorder)
- Current drug or alcohol use disorder (except for nicotine)
- Contraindications to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87110
Chris Abbott, MD, 505-272-2223, cabbott@salud.unm.edu
About this study
Official title: Amplitude Titration to Improve ECT Clinical Outcomes Randomized Clinical Trial
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT:
H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Read the detailed description
ECT dosing can be divided into three categories for the ECT responder: insufficient (no antidepressant response, no cognitive impairment), optimal (antidepressant response, no cognitive impairment), or excessive (antidepressant response, cognitive impairment). Traditional fixed amplitude ECT dosing with 800 mA adjusts pulse train duration and frequency based on seizure titration or demographic factors (age, sex). Fixed amplitude produces variable electric fields and ECT dosing secondary to individual neuroanatomic differences. Adjustments to pulse width, pulse train duration, and frequency do not improve the efficacy of insufficient dosing or mitigate the cognitive risk of excessive dosing. In contrast, individualized amplitude based on electric field modeling or amplitude seizure titration produces consistent electric fields and ECT dosing. Based on our results from the R61 investigation, individualized amplitude with right unilateral electrode placement has the potential to reliably achieve optimal dosing and will be tested with the R33 phase of the investigation.
Subjects will receive baseline imaging, clinical (primary outcome: clinician rated Inventory of Depressive Symptomatology, IDS-C30), and neuropsychological assessment (primary outcome: Delis Kaplan Executive Function System Verbal Fluency, DKEFS) 24 to 48 hours prior to the first ECT session (V1). Subjects will receive their second assessment (V2) one day after the sixth ECT treatment and the final assessment (V3) one day after the ECT series. If the subject fails to demonstrate improvement at V2 (< 25% reduction from baseline IDS-C30 total score, the primary antidepressant outcome), the subject will then receive bitemporal (BT) electrode placement for the remainder of the ECT series. The transition to BT will be a secondary antidepressant outcome. Subjects will be randomized to receive right unilateral (RUL) electrode placement with an individualized amplitude (n = 25) or traditional fixed 800 mA amplitude (n = 25, 1:1 ratio). Subjects and Raters will be blinded to subject assignment. Subjects in both arms will receive fixed pulse width (1.0 milliseconds), frequency (20 hertz), and pulse train duration (8 seconds).
For the individualized amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment like the R61 phase of the investigation (IDE for Soterix adapter: G200123). Subsequent RUL treatments will be completed with an individualized amplitude. To determine the individualized amplitude, we will use Ebrain. The individualized amplitude can be determined from the optimal E-field (V/m) / baseline E-field (V/m per mA). If a discrepancy exists between the amplitude seizure and E-field modeling methods that results in amplitude difference > 100 mA, we will use the E-field modeling method to determine the individualized amplitude. We will round the amplitude to the nearest 100 mA from 500 to 900 mA (the current dosing range of the FDA approved ECT device).
For the fixed 800 mA amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment. The rationale for amplitude titration with the fixed amplitude arm is to 1) improve the goodness of fit of the amplitude-seizure and Ebrain relationship; and 2) control for a sub-therapeutic stimulation associated with the first treatment for both arms. RUL amplitude seizure titration will be conducted during the first treatment like the individualized amplitude arm. Subsequent RUL treatments will be completed with 800 mA amplitude. The only difference between the arms will be individualized versus fixed 800 mA amplitude after amplitude titration.
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT:
H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
- Conditions
- Depression, ECT, Cognitive Change
- Being tested
- Soterix Medical Incorporated 4x1 adapter, Traditional ECT device
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix Medical Incorporated 4x1 adapterDevice
Device permits individualized amplitudes
Traditional ECT deviceDevice
FDA approved ECT device with fixed amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Variable amplitude | Experimental | Individualized amplitude Receives: Device: Soterix Medical Incorporated 4x1 adapter |
| Fixed amplitude | Active comparator | Fixed (800 milliamperes) amplitude Receives: Device: Traditional ECT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Depressive Symptomatology - Clinician Rated
Depression severity, scores from 0 to 84, higher scores indicate more depression severity
Measured: 4 weeks
Delis Kaplan Executive Function System Letter Fluency
Cognitive measure, scale scores range from 0 to 20, higher scores indicate better cognitive performance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start14 Sep 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with two arms: experimental (variable amplitude) and control (fixed amplitude). Participant and outcomes assessor will be masked to assignment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Chris Abbott, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699226
- Sponsor's protocol ID
- R33MH125126
- Other IDs
- 5R61MH125126
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be uploaded to National Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude Titration to Improve ECT Clinical Outcomes Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05699226
- Acronym / sponsor ID
- R33MH125126
- Conditions
- Depression, ECT, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT:
H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Detailed description
ECT dosing can be divided into three categories for the ECT responder: insufficient (no antidepressant response, no cognitive impairment), optimal (antidepressant response, no cognitive impairment), or excessive (antidepressant response, cognitive impairment). Traditional fixed amplitude ECT dosing with 800 mA adjusts pulse train duration and frequency based on seizure titration or demographic factors (age, sex). Fixed amplitude produces variable electric fields and ECT dosing secondary to individual neuroanatomic differences. Adjustments to pulse width, pulse train duration, and frequency do not improve the efficacy of insufficient dosing or mitigate the cognitive risk of excessive dosing. In contrast, individualized amplitude based on electric field modeling or amplitude seizure titration produces consistent electric fields and ECT dosing. Based on our results from the R61 investigation, individualized amplitude with right unilateral electrode placement has the potential to reliably achieve optimal dosing and will be tested with the R33 phase of the investigation.
Subjects will receive baseline imaging, clinical (primary outcome: clinician rated Inventory of Depressive Symptomatology, IDS-C30), and neuropsychological assessment (primary outcome: Delis Kaplan Executive Function System Verbal Fluency, DKEFS) 24 to 48 hours prior to the first ECT session (V1). Subjects will receive their second assessment (V2) one day after the sixth ECT treatment and the final assessment (V3) one day after the ECT series. If the subject fails to demonstrate improvement at V2 (< 25% reduction from baseline IDS-C30 total score, the primary antidepressant outcome), the subject will then receive bitemporal (BT) electrode placement for the remainder of the ECT series. The transition to BT will be a secondary antidepressant outcome. Subjects will be randomized to receive right unilateral (RUL) electrode placement with an individualized amplitude (n = 25) or traditional fixed 800 mA amplitude (n = 25, 1:1 ratio). Subjects and Raters will be blinded to subject assignment. Subjects in both arms will receive fixed pulse width (1.0 milliseconds), frequency (20 hertz), and pulse train duration (8 seconds).
For the individualized amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment like the R61 phase of the investigation (IDE for Soterix adapter: G200123). Subsequent RUL treatments will be completed with an individualized amplitude. To determine the individualized amplitude, we will use Ebrain. The individualized amplitude can be determined from the optimal E-field (V/m) / baseline E-field (V/m per mA). If a discrepancy exists between the amplitude seizure and E-field modeling methods that results in amplitude difference > 100 mA, we will use the E-field modeling method to determine the individualized amplitude. We will round the amplitude to the nearest 100 mA from 500 to 900 mA (the current dosing range of the FDA approved ECT device).
For the fixed 800 mA amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment. The rationale for amplitude titration with the fixed amplitude arm is to 1) improve the goodness of fit of the amplitude-seizure and Ebrain relationship; and 2) control for a sub-therapeutic stimulation associated with the first treatment for both arms. RUL amplitude seizure titration will be conducted during the first treatment like the individualized amplitude arm. Subsequent RUL treatments will be completed with 800 mA amplitude. The only difference between the arms will be individualized versus fixed 800 mA amplitude after amplitude titration.
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT:
H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with two arms: experimental (variable amplitude) and control (fixed amplitude). Participant and outcomes assessor will be masked to assignment.
| Arm | Type | Receives |
|---|---|---|
| Variable amplitude | Experimental | Device: Soterix Medical Incorporated 4x1 adapterIndividualized amplitude |
| Fixed amplitude | Active comparator | Device: Traditional ECT deviceFixed (800 milliamperes) amplitude |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depressive disorder or bipolar II
- Clinical indications for ECT with right unilateral electrode placement
Key exclusion criteria (4 listed)
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
- Other psychiatric conditions (e.g., schizophrenia, bipolar I disorder)
- Current drug or alcohol use disorder (except for nicotine)
- 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 |
|---|---|---|
| Soterix Medical Incorporated 4x1 adapterDevice permits individualized amplitudes | Device | Variable amplitude |
| Traditional ECT deviceFDA approved ECT device with fixed amplitude. | Device | Fixed amplitude |
Primary outcome
Inventory of Depressive Symptomatology - Clinician Rated
Time frame: 4 weeks
Depression severity, scores from 0 to 84, higher scores indicate more depression severity
Delis Kaplan Executive Function System Letter Fluency
Time frame: 4 weeks
Cognitive measure, scale scores range from 0 to 20, higher scores indicate better cognitive performance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be uploaded to National Data Archive.
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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.
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 study testing Soterix Medical Incorporated 4x1 adapter and Traditional ECT device in people with Depression and ECT, 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Abbott, MD (5052720406, cabbott@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Depressive Symptomatology - Clinician Rated (time frame: 4 weeks). 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?
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 26 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.