ECT vs. Ketamine for Depression

(REaKT-SD Trial)

Recruiting at 11 trial locations

Overseen By Sanjay Mathew, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Disqualifiers: Schizophrenia, Schizoaffective, Psychotic features, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for patients with severe depression who are at risk of suicide. One treatment uses electric currents to change brain activity, while the other uses a low dose of a fast-acting drug. The goal is to find out which treatment works better for rapid relief. The drug has recently emerged as a fast-acting alternative for patients with treatment-resistant depression.

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 study team or your doctor.

Is it safe to use ECT and ketamine for depression?

Research shows that using ketamine in low doses is generally safe for treating depression, though it can have side effects like changes in blood pressure and heart rate. ECT is also considered safe, but it may cause temporary memory loss and confusion. ^{1 2 3 4 5}

How is the treatment of ECT combined with ketamine different from other depression treatments?

The combination of electroconvulsive therapy (ECT) with subanesthetic doses of ketamine is unique because it may enhance the rapid antidepressant effects of ECT, potentially improving response rates in treatment-resistant depression. Ketamine is administered intravenously and is known for its quick action, which is different from traditional antidepressants that often take weeks to show effects. ^{2 3 4 6 7}

What data supports the effectiveness of the drug ketamine for depression?

Research shows that ketamine, given in low doses, can quickly reduce symptoms of depression and improve sleep quality in people with major depressive disorder. It has been effective when used alone or alongside electroconvulsive therapy (ECT). ^{2 3 4 6 8}

Who Is on the Research Team?

Amit Anand, MD

Principal Investigator

Brigham and Woman's Hospital, Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with acute suicidal depression who are candidates for ECT treatment. Participants must show ongoing suicidal thoughts and meet criteria for a major depressive episode, but not have schizophrenia or severe cognitive impairment. Pregnant individuals, those unable to consent, or with certain medical conditions like uncontrolled illness or ketamine allergy cannot join.

Inclusion Criteria

My doctor thinks I should get ECT treatment.

I have been diagnosed with a major depressive episode.

Continue to express suicidal ideation since referral as evidenced by Scale for Suicidal Ideation (SSI) ≥6)

Exclusion Criteria

I am not eligible for ECT based on standard guidelines.

I cannot consent to ECT or KET treatment.

I am unable to understand or agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ECT 3 times a week for 4 weeks or subanesthetic dose intravenous ketamine

4 weeks

12 visits (in-person for ECT), multiple visits for ketamine

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroconvulsive therapy (ECT)
• Subanesthetic dose intravenous ketamine (KET)

Trial Overview The study compares the effectiveness of Electroconvulsive therapy (ECT) versus intravenous Ketamine (KET) in treating acute suicidal depression. It's randomized and single-blind, meaning participants won't know which treatment they receive but researchers will.

How Is the Trial Designed?

Group I: Electroconvulsive therapy (ECT) Active Control 1 Intervention

ECT will be given in a standard manner 3 times a week for 4 weeks.

Group II: Subanesthetic dose intravenous ketamine (KET) Active Control 1 Intervention

This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

The Center for Addiction and Mental Health (University of Toronto)

Collaborator

Trials

1

Recruited

1,500+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A 49-year-old woman with severe treatment-resistant major depression experienced significant improvement after receiving 36 sessions of ketamine intravenous therapy over 10 months, resulting in nearly a 50% reduction in her depressive symptoms.

The case suggests that long-term repeated ketamine therapy could be a viable option for patients with treatment-resistant depression, but further research is needed to determine the best treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up. Kwon, JH., Sim, WS., Hong, JP., et al.[2018]

A review of 11 studies, including 7 on humans with major depressive disorder (MDD), found that intravenous ketamine can reduce brain activation related to depression and improve cognitive flexibility without causing significant cognitive impairments in most patients.

Some studies indicated that ketamine may enhance cognitive functions such as processing speed, verbal learning, and attention, suggesting it has a normalizing effect on brain functions involved in emotional processing for MDD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive impact of ketamine treatment in major depressive disorder: A review on human and animal studies. Crisanti, C., Enrico, P., Fiorentini, A., et al.[2021]

Subanaesthetic doses of ketamine have shown substantial efficacy in treating depression, with response rates averaging 77% and remission rates around 43% within 4 to 72 hours after a single dose.

Despite the rapid improvement in mood for many patients, the effects are often short-lived, highlighting the need for further research on dosing regimens and strategies to maintain the antidepressant response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine as a new treatment for depression: a review of its efficacy and adverse effects. Katalinic, N., Lai, R., Somogyi, A., et al.[2013]

Ketamine, at sub-anesthetic doses, shows promise as a rapid-acting treatment for patients with treatment-resistant depression (TRD), potentially improving response rates to electroconvulsive therapy (ECT) when used alone or as an adjunct.

While ketamine can enhance the effectiveness of ECT, it may also increase seizure duration and has been associated with cardiovascular and psychotomimetic side effects, necessitating careful monitoring and consideration of concurrent medications to mitigate risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of ketamine's role in ECT and non-ECT settings. Jankauskas, V., Necyk, C., Chue, J., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up. [2018]

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

Ketamine Augmentation of Electroconvulsive Therapy: A Scoping Review of Dose-Dependent Effects in Major Depressive Disorder. [2023]

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

Subanesthetic Dose of Ketamine Administered Before Each Electroconvulsive Therapy Session Improves Antidepressant and Sleep Quality Outcomes: A Randomized, Controlled Trial. [2023]

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

Effects of Low-Dose Ketamine on the Antidepressant Efficacy and Suicidal Ideations in Patients Undergoing Electroconvulsive Therapy. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neurocognitive impact of ketamine treatment in major depressive disorder: A review on human and animal studies. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Ketamine as a new treatment for depression: a review of its efficacy and adverse effects. [2013]

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

Effect of the Addition of Ketamine to Sevoflurane Anesthesia on Seizure Duration in Electroconvulsive Therapy. [2018]

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

A review of ketamine's role in ECT and non-ECT settings. [2020]