Electroconvulsive Therapy for Mental Illness

Overseen By Heela Azizi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must be taking: Antipsychotics

Must not be taking: Psychotropics

Disqualifiers: Neurological, Endocrine, Suicidal, 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: Unknown

Duration: 8 weeks

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who need medications with psychotropic effects (drugs that affect the mind). It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of electroconvulsive therapy for mental illness?

Research shows that electroconvulsive therapy (ECT) can lead to significant improvements in mental functioning for many patients, with 63% of patients showing much improvement. Additionally, cognitive improvements have been observed in some patients with schizophrenia after ECT treatment. ^{1 2 3 4 5}

Is electroconvulsive therapy (ECT) safe for humans?

Electroconvulsive therapy (ECT) is generally considered safe when done with proper monitoring, but it can have side effects like memory loss, confusion, and headaches. These cognitive side effects are usually temporary, and some studies even show long-term cognitive improvement after ECT. ^{6 7 8 9 10}

How is electroconvulsive therapy different from other treatments for mental illness?

Electroconvulsive therapy (ECT) is unique because it involves sending small electric currents through the brain to quickly improve severe psychiatric conditions, often when other treatments haven't worked. Unlike medications, ECT can provide immediate results and is particularly useful for patients with severe depression or other mental illnesses who need rapid relief. ^{1 8 11 12 13}

What is the purpose of this trial?

In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.

Research Team

Miklos Argyelan, MD

Principal Investigator

The Zucker Hillside Hospital

Eligibility Criteria

This trial is for patients with moderate to severe symptoms of schizophrenia, schizoaffective, or schizophreniform disorder who haven't responded well to at least one antipsychotic drug treatment. Participants must be able to consent and women must use birth control. People with cognitive impairments, MRI contraindications, serious neurological/endocrine disorders, psychotropic medication needs, or significant suicide/homicide risk are excluded.

Inclusion Criteria

I have been diagnosed with schizophrenia or a related disorder.

I experience moderate to severe symptoms like hallucinations or unusual thoughts.

I have tried an antipsychotic medication for 6 weeks without success.

Exclusion Criteria

I have a serious brain or hormone-related condition.

I am taking medication that affects my mood or the way I think.

You have a high risk of wanting to harm yourself or others.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bilateral electroconvulsive therapy and are monitored using fMRI and structural MRI-based electrical field modeling

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clinical and Neuropsychological Testing

Trial Overview The study tests how electroconvulsive therapy (ECT) affects brain circuitry in patients using fMRI and structural MRI-based electrical field modeling. It's a longitudinal study where changes in clinical condition and cognitive performance from baseline until the 8th week of ECT will be measured.

Participant Groups

Group I: Treatment as usual Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study of 231 psychiatric patients undergoing electroconvulsive therapy (ECT), 96% of the evaluated measures showed improvement, with significant enhancements in 37.5% of the measures, indicating that ECT can lead to generally improved functioning.

Patients' pre-ECT cognitive performance was similar to that of individuals with brain damage, but their scores improved to borderline normal levels after treatment, suggesting that ECT may effectively restore cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in neuropsychological test performance after electroconvulsive therapy. Malloy, FW., Small, IF., Miller, MJ., et al.[2015]

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]

In a study of 81 inpatients with schizophrenia undergoing 6 sessions of electroconvulsive therapy (ECT), significant cognitive improvements were observed, particularly in visuospatial/executive function and attention, as measured by the Montreal Cognitive Assessment (MoCA).

Patients with lower pre-treatment MoCA scores experienced the most pronounced cognitive gains, suggesting that ECT may be particularly beneficial for those with more severe cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Study of Cognitive Improvement Following Electroconvulsive Therapy in Schizophrenia Inpatients. Seow, LSE., Subramaniam, M., Chan, YWC., et al.[2020]

In a study of 293 patients with refractory schizophrenia treated with electroconvulsive therapy (ECT) and flupenthixol, 54.6% showed a positive response, indicating ECT can be effective for some individuals with severe symptoms.

Younger patients with shorter illness durations and fewer previous hospitalizations were more likely to respond positively to treatment, while ECT significantly improved positive symptoms but had little effect on negative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined ECT and neuroleptic therapy in treatment-refractory schizophrenia: prediction of outcome. Chanpattana, W., Chakrabhand, ML.[2022]

In a study involving 39 inpatients undergoing electroconvulsive therapy (ECT), those treated with galantamine showed significantly better delayed memory retention compared to those receiving a placebo, suggesting that galantamine may help mitigate cognitive side effects associated with ECT.

Galantamine was found to be safe and well-tolerated during ECT, with no significant adverse effects like bradycardia or prolonged paralysis, indicating its potential as a protective agent for cognitive function in patients receiving ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of the impact of galantamine on anterograde memory impairment during electroconvulsive therapy. Matthews, JD., Siefert, CJ., Blais, MA., et al.[2013]

Electroconvulsive therapy (ECT) is a safe and effective treatment for severe mental disorders when conducted with proper monitoring.

Common side effects of ECT include anterograde amnesia, post-ictal confusion, and physical discomforts like nausea and headaches, but these are generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RECURRENT SELF-LIMITED HYPERTHERMIA FOLLOWING ELECTROCONVULSIVE THERAPY. Sánchez-Morla, EM., Gómez de Las Heras, V.[2023]

In a study of 20 treatment-resistant and ECT-naive patients, electroconvulsive therapy (ECT) did not result in any adverse cognitive effects, confirming its safety regarding cognitive functioning.

While there was an initial improvement in verbal working memory after ECT, this effect disappeared when accounting for changes in depressive symptoms, suggesting that the perceived cognitive benefits may be linked to mood improvement rather than a direct effect of ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Performance Under Electroconvulsive Therapy (ECT) in ECT-Naive Treatment-Resistant Patients With Major Depressive Disorder. Ziegelmayer, C., Hajak, G., Bauer, A., et al.[2018]

In a study of 84 patients referred for electroconvulsive therapy (ECT), 71% completed a pre-treatment cognitive assessment, highlighting a significant gap in cognitive testing participation.

Patients with unipolar depression and psychotic symptoms, especially those receiving bitemporal electrode placement, were more likely to skip cognitive assessments, suggesting they may be at greater risk for cognitive side effects from ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Practice of Assessing Cognitive Function in Adults Receiving Electroconvulsive Therapy: Whom Are We Missing? Obbels, J., Vanbrabant, K., Bouckaert, F., et al.[2017]

In a study of 31 patients with major depressive disorder, electroconvulsive treatment (ECT) led to significant improvements in cognitive functions such as Speed of Processing, Attention/Vigilance, and Visual Learning six weeks post-treatment.

Despite these cognitive improvements, patients did not report significant changes in their everyday cognitive complaints, indicating a disconnect between objective cognitive performance and subjective experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significantly improved neurocognitive function in major depressive disorders 6 weeks after ECT. Mohn, C., Rund, BR.[2022]

In a study of 154 patients receiving electroconvulsive therapy (ECT) for major depression, reducing the electrical stimulus dose from high to moderate significantly decreased the risk of subjective memory worsening from 44% to 25%.

Despite the lower dosage leading to fewer memory issues, the effectiveness of ECT in alleviating depressive symptoms remained unchanged, indicating that it is possible to minimize cognitive side effects without sacrificing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Less memory complaints with reduced stimulus dose during electroconvulsive therapy for depression. Kronsell, A., Nordenskjöld, A., Tiger, M.[2020]

Electroconvulsive therapy (ECT) significantly reduced depression symptoms in 46 patients, as shown by a decrease in the Beck Depression Inventory scores, indicating its efficacy in treating severe depression.

However, ECT was associated with objective declines in memory performance, suggesting that cognitive risks should be discussed with patients prior to treatment, as self-reports of memory issues may not always reflect actual changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological effects and attitudes in patients following electroconvulsive therapy. Feliu, M., Edwards, CL., Sudhakar, S., et al.[2022]

Electroconvulsive therapy (ECT) is an effective treatment option for certain severely ill psychiatric patients, providing immediate therapeutic responses.

With careful patient selection and a thorough understanding of ECT, the treatment can be administered with minimal risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy. Cephus, P., Collins, RF., Callies, BL.[2004]

Current guidelines for electroconvulsive therapy (ECT) do not clearly define the type of cognitive testing that should be routinely conducted, despite decades of research on ECT's cognitive effects.

There is a need for further research to establish effective cognitive testing protocols during and after ECT, as practical utility and specific testing parameters remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Type of Cognitive Testing Should Be Part of Routine Electroconvulsive Therapy Practice? Rasmussen, KG.[2016]

References

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

Changes in neuropsychological test performance after electroconvulsive therapy. [2015]

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

Electroconvulsive treatment--indications, benefits, and limitations. [2018]

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

A Retrospective Study of Cognitive Improvement Following Electroconvulsive Therapy in Schizophrenia Inpatients. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Combined ECT and neuroleptic therapy in treatment-refractory schizophrenia: prediction of outcome. [2022]

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

A double-blind, placebo-controlled study of the impact of galantamine on anterograde memory impairment during electroconvulsive therapy. [2013]

6. Spain pubmed.ncbi.nlm.nih.gov

RECURRENT SELF-LIMITED HYPERTHERMIA FOLLOWING ELECTROCONVULSIVE THERAPY. [2023]

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

Cognitive Performance Under Electroconvulsive Therapy (ECT) in ECT-Naive Treatment-Resistant Patients With Major Depressive Disorder. [2018]

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

The Clinical Practice of Assessing Cognitive Function in Adults Receiving Electroconvulsive Therapy: Whom Are We Missing? [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Significantly improved neurocognitive function in major depressive disorders 6 weeks after ECT. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Less memory complaints with reduced stimulus dose during electroconvulsive therapy for depression. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychological effects and attitudes in patients following electroconvulsive therapy. [2022]

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

Electroconvulsive therapy. [2004]

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

What Type of Cognitive Testing Should Be Part of Routine Electroconvulsive Therapy Practice? [2016]