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

Trial Summary

What is the purpose of this 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

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 data supports the effectiveness of the treatment Amplitude Titration, Electroconvulsive Therapy Amplitude Titration, Individualized Amplitude ECT for depression?

Research shows that adjusting the electrical dose in electroconvulsive therapy (ECT) to match individual needs can be more effective than using a standard dose, as it accounts for differences in how patients respond to the treatment. This individualized approach helps maintain the treatment's effectiveness while potentially reducing side effects. ^{1 2 3 4 5}

Is electroconvulsive therapy (ECT) safe for humans?

ECT is generally considered safe, but it can have risks like skin burns and cardiovascular effects. Adjusting the electrical dose can help reduce side effects, and subconvulsive stimuli are usually well tolerated. ^{3 6 7 8 9}

How is Amplitude Titration ECT different from other depression treatments?

Amplitude Titration ECT is unique because it customizes the electrical dose for each patient based on their individual seizure threshold, unlike standard ECT methods that use a fixed or age-based dose. This personalized approach aims to improve treatment effectiveness and reduce side effects by ensuring the electrical stimulus is neither too low nor excessively high. ^{3 10 11 12 13}

Research Team

Chris Abbott, MD

Principal Investigator

University of New Mexico

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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) 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Antidepressant electroconvulsive therapy: mechanism of action, recent advances and limitations. [2009]

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Electrical dose titration for electroconvulsive therapy: a comparison with dose prediction methods. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy Stimulus Dosing: A Survey of Contemporary Practices. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Argentina pubmed.ncbi.nlm.nih.gov

[Electroconvulsive therapy: indications and improvement]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy stimulus parameters: rethinking dosage. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic and cardiovascular effects of subconvulsive stimulation during titrated right unilateral ECT. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Dosing methods in electroconvulsive therapy: should the Scandinavian time-titration method be resumed? [2022]

11. Hungary pubmed.ncbi.nlm.nih.gov

[Strategies for optimizing stimulus dosage during electroconvulsive therapy]. [2008]

12. Spain pubmed.ncbi.nlm.nih.gov

Stimulus characteristics in electroconvulsive therapy. A pragmatic review. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy. [2019]