ECT Methods for Depression

Overseen By Megan Lloyd, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Neurological disorders, Schizophrenia, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways of delivering electroconvulsive therapy (ECT) to treat depression. Specifically, it compares a fixed electric current method with a personalized method, known as Amplitude Titration, which adjusts the current for each participant. The goal is to determine which method more effectively improves mood and thinking abilities. Suitable participants have major depressive disorder or bipolar II and are already recommended for ECT with right-side electrode placement. As an unphased trial, this study allows participants to contribute to innovative research that could enhance ECT treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these ECT methods are safe for depression?

Previous studies on electroconvulsive therapy (ECT) with adjustable strength have shown mixed results. Research suggests that altering the electrical current's strength can improve depression but might also impact thinking and memory.

Studies have found that a personalized approach to ECT, where the strength is adjusted for each individual, might be more effective for treating depression than a fixed strength of 800 milliamperes (mA) for everyone. This personalized method could lead to better outcomes and fewer side effects.

Regarding safety, research on adjustable strength ECT continues. Evidence indicates that stronger electrical currents can improve depression symptoms but may also cause more issues with thinking and memory. So far, this treatment appears generally well-tolerated, but more studies are needed to fully understand the benefits and risks.

In summary, while personalized ECT shows promise, awareness of possible effects on thinking and memory is important. Consulting with a healthcare provider can help determine if this approach is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method of administering Electroconvulsive Therapy (ECT) for depression, focusing on amplitude titration. Traditional ECT treatments typically use a fixed amplitude, but this trial is testing an individualized approach where the amplitude is adjusted to suit each patient. This could potentially enhance the effectiveness of ECT by tailoring the treatment to the individual's needs, possibly improving outcomes and reducing side effects. By examining both fixed and variable amplitudes, the trial aims to find out whether personalized treatment can offer better results than the one-size-fits-all approach.

What evidence suggests that this trial's treatments could be effective for depression?

This trial will compare two methods of electroconvulsive therapy (ECT) for depression: a fixed amplitude and a variable amplitude approach. Research has shown that personalizing the strength of ECT, as in the variable amplitude arm, can improve depression treatment. Studies have found that adjusting the ECT's power level to fit each person can lead to better relief from depression symptoms than using the same power level for everyone, as in the fixed amplitude arm. These adjustments might also help preserve memory and thinking skills after treatment. Previous research suggests that while stronger ECT doses can be more effective, they can also affect memory and thinking. By fine-tuning the treatment's power, the aim is to enhance effectiveness while reducing side effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Chris Abbott, MD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

This trial is for older adults with major depressive disorder or bipolar II who need ECT treatment. Participants should be suitable for right unilateral electrode placement. It's not specified, but typically those with certain health conditions or incompatible treatments would be excluded.

Inclusion Criteria

I have been diagnosed with major depression or bipolar II.

I am recommended to undergo ECT with electrodes placed on the right side of my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Subjects receive baseline imaging, clinical, and neuropsychological assessment 24 to 48 hours prior to the first ECT session

1 week

1 visit (in-person)

Treatment

Subjects receive ECT treatment with either individualized amplitude or fixed 800 mA amplitude, with assessments after the sixth treatment and at the end of the series

4 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amplitude Titration

Trial Overview The study is testing if adjusting the electric current (amplitude) during ECT can improve depression and cognitive outcomes compared to a fixed amplitude of 800 mA. Half of the participants will receive individualized amplitude adjustments, while the other half will get the standard fixed level.

How Is the Trial Designed?

Group I: Variable amplitude Experimental Treatment 1 Intervention

Individualized amplitude

Group II: Fixed amplitude Active Control 1 Intervention

Fixed (800 milliamperes) amplitude

Amplitude Titration is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electroconvulsive Therapy for:

• Major depressive disorder
• Bipolar disorder
• Schizophrenia

Approved in European Union as Electroconvulsive Therapy for:

• Major depressive disorder
• Bipolar disorder
• Schizophrenia
• Catatonia

Approved in Canada as Electroconvulsive Therapy for:

• Major depressive disorder
• Bipolar disorder
• Schizophrenia

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Electroconvulsive therapy (ECT) carries several accidental risks, including skin burns and misdelivery of the electrical stimulus, which can affect treatment efficacy and patient safety.

Understanding and preventing these risks is crucial for improving the safety and effectiveness of ECT as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and ECT Stimulus Electrodes: II. Clinical Procedures. Swartz, CM.[2019]

Electroconvulsive therapy (ECT) is recognized as an effective and safe treatment for certain mental health conditions, although some of its uses are based more on professional consensus than solid clinical research.

The effectiveness and side effects of ECT can vary widely among patients, highlighting the importance of understanding individual factors that may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electroconvulsive therapy: indications and improvement]. Colin Piana, R.[2006]

A nationwide study revealed significant variability in electroconvulsive therapy (ECT) practices among practitioners, including how they determine the initial stimulus intensity for treatment.

Both ECT specialists and nonspecialists commonly used fixed high-dose stimuli and various methods for calculating stimulus intensity, indicating a lack of consensus on optimizing ECT administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy Stimulus Dosing: A Survey of Contemporary Practices. Farah, A., McCall, WV.[2019]

Electroconvulsive therapy (ECT) is recognized as a highly effective treatment for severe depression, but its efficacy can be significantly reduced if administered with a low-dose electric stimulus.

While there is ongoing debate about the optimal dosage and the contributions of electrical energy versus convulsions to ECT's effectiveness, it is crucial that treatment protocols do not overly reduce dosages in an attempt to minimize side effects, as this may compromise therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy for depression in general psychiatric practice. Martin, BA.[2005]

In a study involving older adults with major depressive disorder, higher pulse amplitudes (700 and 800 mA) during electroconvulsive therapy (ECT) led to better depression outcomes compared to a lower amplitude (600 mA).

However, while higher amplitudes improved depression symptoms, they also resulted in cognitive impairments, particularly in the 800 mA group, suggesting a trade-off between efficacy and cognitive safety that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Abbott, CC., Quinn, D., Miller, J., et al.[2022]

Electroconvulsive therapy (ECT) outcomes can be significantly influenced by specific electrical stimulus parameters, such as pulse amplitude, shape, and duration, rather than just summary metrics like charge and energy.

Adjusting these parameters, such as reducing pulse width and increasing the number of pulses, has been shown to decrease adverse effects while maintaining the effectiveness of ECT, suggesting a need for more individualized dosing strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy stimulus parameters: rethinking dosage. Peterchev, AV., Rosa, MA., Deng, ZD., et al.[2022]

Electroconvulsive therapy (ECT) is gaining renewed interest as a non-pharmacological treatment for depression, especially for patients who do not respond to traditional therapies, with ongoing research enhancing its efficacy and safety.

Recent studies indicate that the placement of electrodes and the dosage relative to seizure threshold significantly influence both the effectiveness and side effects of ECT, highlighting the importance of optimizing these parameters for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant electroconvulsive therapy: mechanism of action, recent advances and limitations. Merkl, A., Heuser, I., Bajbouj, M.[2009]

The Scandinavian time-titration method for ECT, which uses low-frequency pulses and long pulse durations, has shown high efficacy comparable to bitemporal ECT, but its use has declined due to the discontinuation of the necessary devices in the 1990s.

While no single dosing method for ECT is proven to be superior, seizure threshold-based and benchmark dosing methods are more precise than fixed high or formula-based methods, with time-titration allowing for dose adjustments at each session, potentially making it the most efficient approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing methods in electroconvulsive therapy: should the Scandinavian time-titration method be resumed? Bergsholm, P., Bjølseth, TM.[2022]

The review highlights the importance of understanding the electrical stimulus parameters in electroconvulsive therapy (ECT), including frequency, number of sessions, and electrode placement, to optimize treatment efficacy.

It discusses two methods for determining the ECT charge—stimulus titration and age-based approaches—while emphasizing the need for a deeper understanding of various stimulus parameters like duration and current amplitude to improve ECT outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulus characteristics in electroconvulsive therapy. A pragmatic review. Sanz-Fuentenebro, FJ.[2021]

Electroconvulsive therapy (ECT) has been an effective treatment for depression since its introduction in 1938, but the variability in treatment outcomes is largely due to inconsistent measurement of electrical parameters during the procedure.

Accurate measurement of peak current and voltage during ECT is crucial, as it highlights the need for tailored current values to improve the consistency and efficacy of treatment results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy. Gordon, D.[2019]

The study found that using empirical titration to determine the electrical stimulus dose for electroconvulsive therapy (ECT) provides a more consistent and individualized approach compared to two predictive methods from ECT equipment manuals.

Individualizing the ECT stimulus dose is important due to the significant variability in seizure thresholds among patients, which can enhance the efficacy and safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical dose titration for electroconvulsive therapy: a comparison with dose prediction methods. Enns, M., Karvelas, L.[2006]

In a study of 40 inpatients with major depression, subconvulsive stimuli during titrated right unilateral electroconvulsive therapy (ECT) were found to be well tolerated, showing only minor changes in heart rate and ECG that were not clinically significant.

The findings suggest that using subconvulsive stimuli for dose titration in ECT does not pose significant cardiovascular risks, allowing for potential optimization of treatment efficacy with fewer cognitive side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic and cardiovascular effects of subconvulsive stimulation during titrated right unilateral ECT. McCall, WV., Reid, S., Ford, M.[2007]

In a study of 40 patients with schizophrenia undergoing electroconvulsive therapy (ECT), the age method was found to be the most effective way to determine the initial stimulus intensity needed to induce a seizure, which is crucial for the therapy's success.

The average stimulus intensity required to elicit a seizure lasting at least 20 seconds was 18.37%, with a significant positive correlation between patient age and the required intensity, indicating that older patients may need higher stimulus levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strategies for optimizing stimulus dosage during electroconvulsive therapy]. Gazdag, G., Tolna, J., Iványi, Z.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05699226

Amplitude Titration to Improve ECT Clinical Outcomes A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7744398/

Electroconvulsive Therapy Pulse Amplitude and Clinical ... Recent, small (n = 7–22) investigations have demonstrated that low amplitude ECT results in improvement of depression severity and reduced ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04621786

Electroconvulsive Therapy Amplitude Titration Inclusion Criteria: Diagnosis of major depressive disorder; Clinical indications for ECT with right unilateral electrode placement; Right-handed; Age range ...

4. nature.com nature.com/articles/s41386-023-01780-4

Amplitude-determined seizure-threshold, electric field ... We have previously demonstrated that increased E-field strength improves ECT's antidepressant effect but worsens cognitive outcomes.

5. grantome.com grantome.com/grant/NIH/R61-MH125126-01

Electroconvulsive therapy amplitude titration for improved ... Amplitude titration, as proposed in this current proposal, can reduce the variability related to fixed amplitude dosing and optimize clinical and cognitive ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04621786/electroconvulsive-therapy-amplitude-titration

Electroconvulsive Therapy Amplitude Titration This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters ...