Electroconvulsive Therapy for Depression

(PRESTO Trial)

ZR
MC
Overseen ByMario Cristancho, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
Must be taking: ECT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve electroconvulsive therapy (ECT) for treating depression. Researchers aim to find the best ECT settings by studying brain responses, including seizures and a new brain event called cortical spreading depolarization (CSD). Participants receive different ECT settings and are monitored to assess the effects on their brains and symptoms. This trial is open to individuals already receiving ECT at Pennsylvania Hospital who can participate in additional monitoring during their treatment. As an unphased trial, it offers a unique opportunity to advance ECT treatment methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this method is safe for improving ECT stimulation settings?

Research shows that electroconvulsive therapy (ECT) is generally a safe treatment for depression and proves effective, especially when other treatments have failed. Patients often tolerate ECT well, and it has been in use for many years.

In the "Frequency-then-Duration" approach, research indicates that ECT is a low-risk procedure that helps treat depression, suicidal thoughts, and severe mental illness. Some side effects, like temporary memory loss, can occur, but they are usually mild and short-lived.

With the "Duration-then-Frequency" method, ECT also maintains a strong safety record. Some studies suggest it might cause slightly more confusion or memory problems at higher electric levels, but these effects are generally mild and temporary.

Overall, ECT is considered a safe option for those dealing with severe depression. Past studies support its safety, making it a reliable choice for many.12345

Why are researchers excited about this trial?

Most treatments for depression, like medications and psychotherapy, can take weeks to show results. Electroconvulsive Therapy (ECT) is unique because it can provide relief much faster, often within days. Researchers are excited about exploring different ECT protocols because they may improve how effectively and safely ECT works. By experimenting with variations in the frequency and duration of ECT sessions, the trial aims to optimize its benefits and reduce side effects, potentially offering a more tailored and efficient treatment for individuals with depression.

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

Research has shown that Electroconvulsive Therapy (ECT) effectively treats depression. For instance, it helps 73% of people with moderate to severe depression feel better, and 51% experience complete relief from their symptoms. In another large study, 68% of patients reported feeling "much improved" or "very much improved" after ECT. This treatment also quickly reduces suicidal thoughts, with over 60% of patients feeling better within two weeks. Overall, ECT often outperforms medication for severe depression and can rapidly improve symptoms. Participants in this trial will receive assignments to different ECT treatment arms, including variations in titration methods and maintenance protocols, to evaluate the effectiveness of these approaches.678910

Are You a Good Fit for This Trial?

This trial is for patients at Pennsylvania Hospital who are already receiving electroconvulsive therapy (ECT) and are willing to participate. People can't join if they have other serious psychiatric or medical conditions, a history of poor ECT response, or can't safely complete the study.

Inclusion Criteria

I am receiving electroconvulsive therapy at Pennsylvania Hospital and can participate.

Exclusion Criteria

They are unwilling or unable to consent first to the SWEET COMBO protocol for optical monitoring during ECT
Clinically significant psychiatric comorbidity as determined by clinical interview and in the opinion of the Investigator and clinical team would alter the risk/benefit of the study
History of poor response to ECT treatment in the opinion of the Investigator and clinical team that would alter the risk/benefit of the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Index ECT Treatment

Participants starting ECT will receive different standard titration approaches. Monitoring includes EEG and blood flow measurements.

4-6 weeks
12 visits (3 times/week)

Maintenance ECT Treatment

Clinically stable patients receive monthly maintenance ECT with sub-convulsive stimulation settings.

8 months
8 visits (once a month)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Electroconvulsive Therapy

Trial Overview

Researchers are studying different ways to set up ECT by monitoring brain activity in real time. Participants will be assigned to groups based on whether they're starting or continuing ECT, with adjustments made to stimulation settings during treatment.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: MaintenanceExperimental Treatment1 Intervention
Group II: Index: Frequency-then-durationExperimental Treatment1 Intervention
Group III: Index: Duration then FrequencyExperimental Treatment1 Intervention
Group IV: Index: Standard titration tableActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Electroconvulsive therapy response and remission in ...

ECT is highly effective for moderate to severe depression, with a response rate of 73% and remission rate of 51%.

Efficacy of electroconvulsive therapy as a potential first-choice ...

The effectiveness of ECT in treating depression is already well known. Comparative studies have shown that ECT has a greater antidepressant effect than other ...

Depression Remission and Response Rates and Anxiety ...

Results: Depression response and remission rates were 54.3% and 31.4%, respectively. This was a highly treatment-resistant sample, with an ...

Modern Electroconvulsive Therapy: Vastly Improved yet ...

In a 2016 large multisite study in geriatric depression, this form of ECT resulted in a 62% remission rate. At the time of the introduction of ...

Electroconvulsive therapy reduces suicidality and all-cause ...

We observed a moderate reduction in suicidal ideation with ECT, as assessed by standardized tools in studies focusing on this outcome. However, such an effect ...

Amplitude-determined seizure-threshold, electric field ...

We have previously demonstrated that increased E-field strength improves ECT's antidepressant effect but worsens cognitive outcomes.

Electroconvulsive Therapy Pulse Amplitude and Clinical ...

Subjects randomized to the 600 mA arm had worse post-ECT depression outcomes relative to the 700 and 800 mA arms.

Comparison of High-Charge Protocol vs. Dose Titration ... - PMC

The aim of this study is to compare the effectiveness of two charges' dosing protocols—High-Charge Protocol (HCP; based on the modified age- ...

Electroconvulsive therapy

Electroconvulsive therapy (ECT) is a psychiatric treatment that causes a generalized seizure by passing electrical current through the brain.

Frequency and Duration of Course of ECT Sessions - PMC - NIH

This paper aims to review the recent literature regarding factors influencing the frequency and number of sessions during a course of electroconvulsive therapy ...