EEG Markers for ECT Response in Depression

Not currently recruiting at 1 trial location

Overseen By Orlandrea Hyche

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Schizophrenia, Schizoaffective, 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: 22

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the relationship between changes in brain wave patterns, observed in electroencephalograms (EEGs), and improvements in depression symptoms following electroconvulsive therapy (ECT). ECT uses electrical currents to affect brain activity and is often used for severe depression that resists other treatments. The trial seeks individuals who have struggled with depression despite trying various treatments, including those with treatment-resistant depression or depression with psychotic symptoms. As an unphased trial, this study offers a unique opportunity to contribute to understanding depression treatment and potentially benefit from innovative approaches.

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 coordinators or your doctor.

What prior data suggests that electroconvulsive therapy (ECT) is safe for patients with treatment-resistant depression?

Research has shown that electroconvulsive therapy (ECT) is generally safe for treating severe mental health conditions. Studies have found that while ECT can temporarily affect memory and thinking, these issues often improve or stabilize within six months. ECT has been used for about 80 years and is effective, especially for depression that doesn't respond to other treatments.

ECT is considered safe even for older adults with severe conditions, making it a dependable option. It also helps lower the risk of suicide and death in patients. Although some short-term side effects may occur, they are usually manageable, and the benefits often outweigh the risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Electroconvulsive Therapy (ECT) is unique because it offers a rapid response for patients with treatment-resistant depression, often working in cases where other treatments like antidepressants and psychotherapy have failed. Unlike medications that can take weeks to show effects, ECT can lead to significant improvements in mood within just a few sessions. Researchers are excited about ECT because it provides a different mechanism of action, using controlled electrical currents to induce seizures that can reset brain chemistry and improve mood. This method is particularly promising for those who have not responded to other forms of treatment, offering a new hope for managing severe depression.

What is the effectiveness track record for Electroconvulsive Therapy (ECT) in treating depression?

Research shows that electroconvulsive therapy (ECT), which participants in this trial will receive, works well for people with depression that hasn't improved with other treatments. Studies have found that 70% to 90% of these patients respond well to ECT. It can quickly ease severe depression symptoms and help with other mental health issues. ECT has also been shown to lower the risk of suicide by 34% and reduce the overall risk of death. While symptoms can return after treatment, ECT remains one of the fastest and most effective options for those who haven't found relief with other methods. ^{1 2 3 5 6}

Who Is on the Research Team?

MohammadMehdi Kafashan

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults (18+) referred for ECT to treat resistant depression, including major depressive disorder with or without psychotic symptoms, and those with schizophrenia or schizoaffective disorder currently experiencing a depressed episode.

Inclusion Criteria

I am referred for ECT due to treatment-resistant depression or a related condition.

Exclusion Criteria

I have schizophrenia or schizoaffective disorder and am not currently being treated for depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo up to 22 ECT sessions with EEG monitoring to assess depression severity and EEG markers

8 weeks

Up to 22 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ECT treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroconvulsive Therapy (ECT)

Trial Overview The study aims to correlate changes in depression symptoms with EEG patterns following electroconvulsive therapy. It involves measuring post-ictal EEG suppression, sleep microstructure, closed loop acoustic stimulation effects, and using the QIDS-SR16 scale.

How Is the Trial Designed?

Group I: Patients with Treatment-Resistant Depression Experimental Treatment 6 Interventions

Electroconvulsive Therapy (ECT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electroconvulsive Therapy for:

• Severe depression
• Bipolar disorder
• Schizophrenia
• Catatonia
• Agitation in dementia (off-label)

Approved in European Union as Electroconvulsive Therapy for:

• Severe depression
• Bipolar disorder
• Schizophrenia
• Catatonia
• Agitation in dementia (off-label)

Approved in Canada as Electroconvulsive Therapy for:

• Severe depression
• Bipolar disorder
• Schizophrenia
• Catatonia
• Agitation in dementia (off-label)

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Electroconvulsive therapy (ECT) is generally a safe and effective treatment for psychiatric disorders, but it can lead to rare complications such as prolonged seizures, as demonstrated in a case involving an 83-year-old female patient.

In this case, the patient experienced a prolonged seizure lasting about 700 seconds during her third ECT session, highlighting the need for careful monitoring and the development of preventive protocols to manage such risks in future ECT treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epileptic status as a complication of electroconvulsive therapy: a case report. Reyes-Molón, L., Trebbau-López, H., Saiz-González, D.[2012]

In a study of 261 patients undergoing Electroconvulsive Therapy (ECT) over four years, 63% showed significant improvement, indicating ECT can be an effective treatment for severe mental health conditions.

Response to ECT was not predicted by most clinical and neuropsychological assessments, but was associated with factors like history of substance abuse and specific psychiatric ratings, suggesting that individual patient history may play a crucial role in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive treatment--indications, benefits, and limitations. Small, IF., Milstein, V., Miller, MJ., et al.[2018]

Electroconvulsive therapy (ECT) is a highly effective and safe treatment for severe affective disorders, gaining popularity due to limitations in other psychopharmacological treatments.

The paper emphasizes the importance of proper training for medical staff administering ECT and suggests monitoring their competence to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy: an update. Coffey, CE., Weiner, RD.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8461517/

Efficacy of electroconvulsive therapy as a potential first- ... In a naturalistic ECT study, results showed transient impairment in memory and executive function with improvement or stabilizing in the subsequent six months.

2. mayoclinic.org mayoclinic.org/tests-procedures/electroconvulsive-therapy/about/pac-20393894

Electroconvulsive therapy (ECT) This procedure can greatly and rapidly improve severe symptoms of depression, mania, catatonia or other mental health conditions.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772408525001127

Electroconvulsive therapy reduces suicidality and all-cause ... Thus, treatment with ECT demonstrated a significant 34 % decrease in the odds of suicide (OR 0.66, 95 % CI 0.50–0.88, p = 0.0047) and a 30 % reduction of death ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3650296/

Follow-up Study on Electroconvulsive Therapy in ... In recent reports, 70% to 90% of patients with TRD responded to ECT. However, post-ECT relapse is a significant problem. There are no studies investigating risk ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2302399

Ketamine versus ECT for Nonpsychotic Treatment ... Electroconvulsive therapy (ECT) has a track record of nearly 80 years as one of the most effective and rapid strategies for treatment-resistant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259509/

Recent advances in electroconvulsive therapy in clinical ... ECT remains one of the most effective and relatively safe treatments in psychiatry. It is a safe treatment in the elderly population with severe ...