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Electroconvulsive Therapy

ECT vs. Ketamine for Depression (REaKT-SD Trial)

Phase 4

Waitlist Available

Led By Amit Anand, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet DSM-5 criteria for Major Depressive Episode (MDE) as determined by Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)

Be older than 18 years old

Must not have

Not able to give informed consent to receive ECT or KET treatment

Not able to give informed consent to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

ECT may cause temporary confusion, memory loss, physical side effects like headaches or muscle aches. Ketamine can lead to dissociation (feeling detached from reality), dizziness, nausea, increased blood pressure and potentially abuse due to its psychoactive properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a major depressive episode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot consent to ECT or KET treatment.

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

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I have been diagnosed with schizophrenia or a related disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Scale for Suicidal Ideation (SSI)

Secondary study objectives

Brief Psychiatric Rating Scale 4 items (BPRS)

CGI-I

CGI-S

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Electroconvulsive therapy (ECT)Active Control1 Intervention

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

Group II: Subanesthetic dose intravenous ketamine (KET)Active Control1 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.

0 / 4Eligibility criteria met