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ECT with Ketamine vs High-Intensity Ketamine for Depression

Phase 4

Recruiting

Led By Jonathan Gamble, MD

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

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

Must have

Montgomery Asberg Depression Rating Scale (MADRS) score of greater than 20) planned for ECT therapy

Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks

Awards & highlights

Study Summary

This trial is testing whether a high-intensity ketamine treatment approach can help people with treatment-resistant depression, by reducing symptoms, side effects, and the need for ECT.

Who is the study for?

This trial is for adults with treatment-resistant depression, defined as not responding to at least two standard drug therapies. Participants must have a significant level of depression (MADRS score >20) and be planned for ECT therapy. It's not for those with severe physical health risks, electronic medical implants, schizoaffective disorder, pregnant women or those who could become pregnant and refuse testing.Check my eligibility

What is being tested?

The study compares two approaches: HIKER involves high intensity ketamine treatments over eight days; EAST combines ECT with ketamine anesthesia across 2-3 sessions per week. The goal is to see if HIKER can quickly alleviate symptoms with fewer side effects and reduce the need for ECT.See study design

What are the potential side effects?

Ketamine may cause disorientation, nausea, increased blood pressure, mood swings or dissociation. ECT might lead to memory loss, muscle soreness or headaches. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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My depression is severe, scoring over 20 on MADRS, and I am planning for ECT therapy.

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I have depression that didn't improve after trying at least 2 different treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of treatments required to reach disease remission

Secondary outcome measures

Cognitive Impairment

Patient satisfaction with treatment

Rate of rescue ECT in the HIKER arm

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketamine (HIKER)Experimental Treatment1 Intervention

Patients in the HIKER arm will receive a single dose of ketamine 0.50 mg/kg, which is enough to achieve a full anaesthetic effect (i.e., unconsciousness mimicking the GA regimen above), on 8 successive weekdays.

Group II: Ketamine-ECT (EAST)Active Control2 Interventions

Patients in the EAST arm will initially receive intravenous ketamine 0.75 mg/kg, remifentanil 1 mcg/kg (to reduce discomfort), and succinylcholine 0.75 mg/kg (for safety). Based on patients' anaesthetic response, the attending anaesthesiologist is given the freedom to vary the dose of remifentanil and succinylcholine as well as administer propofol to achieve safe and acceptable anaesthetic conditions. As per the Saskatoon Health Region's care standard, patients in the EAST arm will receive eight ECT sessions (on a bi/triweekly schedule) delivered by the attending psychiatrist with either unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor

251 Previous Clinical Trials

154,348 Total Patients Enrolled

Royal University Hospital FoundationOTHER

22 Previous Clinical Trials

7,486 Total Patients Enrolled

Jonathan Gamble, MDPrincipal InvestigatorUniversity of Saskatchewan

4 Previous Clinical Trials

464 Total Patients Enrolled

Media Library

ECT Clinical Trial Eligibility Overview. Trial Name: NCT03272698 — Phase 4

Major Depressive Disorder Research Study Groups: Ketamine-ECT (EAST), Ketamine (HIKER)

Major Depressive Disorder Clinical Trial 2023: ECT Highlights & Side Effects. Trial Name: NCT03272698 — Phase 4

ECT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03272698 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted official authorization to use Ketamine?

"We have rated Ketamine's safety as a 3, signifying that it has been approved by the FDA and is safe to use in Phase 4 clinical trials."

Answered by AI

What is the number of people being recruited to participate in this medical experiment?

"Affirmative. Per the records uploaded on clinicaltrials.gov, this medical experiment is currently seeking volunteers. The trial was first listed on September 1st 2017 and most recently updated on October 31st 2022, with 62 patients being sought from a single hospital institution."

Answered by AI

Is enrollment for this clinical research still open at present?

"Per the information currently available on clinicaltrials.gov, this trial is still actively looking for participants and has been since its initial posting on September 1st 2017 with a recent update occurring October 31st 2022."

Answered by AI