Electroconvulsive Therapy for Depression

(PRESTO Trial)

Overseen By Mario Cristancho, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: ECT

Disqualifiers: Psychiatric comorbidity, poor ECT response, others

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

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD).

The main questions it aims to answer are:

What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure?

Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups:

Index ECT group: Participants starting ECT will receive different standard titration approaches.

Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment.

All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.

Are You a Good Fit for This Trial?

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

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

How Is the Trial Designed?

Group I: Maintenance Experimental Treatment 1 Intervention

Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols

Group II: Index: Frequency-then-duration Experimental Treatment 1 Intervention

ECT provided using Table 2, frequency uptitration followed by duration uptitration

Group III: Index: Duration then Frequency Experimental Treatment 1 Intervention

ECT provided using Table 3, duration titration then frequency titration

Group IV: Index: Standard titration table Active Control 1 Intervention

Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+