Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

Conditions

• Acute Suicidal Depression (ASD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Subanesthetic dose intravenous ketamine (KET) — DRUG
  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. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.
• Electroconvulsive therapy (ECT) — DEVICE
  ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.

Study Details

This study is a randomized open-label single-blind non-inferiority comparative effectiveness study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).

Key Dates

Start date

Oct 1, 2023

Status verified

Dec 2025

Primary completion

Oct 1, 2030

Completion

Dec 1, 2030

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Subanesthetic dose intravenous ketamine (KET)
  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.
• Active Comparator: Electroconvulsive therapy (ECT)
  ECT will be given in a standard manner 3 times a week for 4 weeks.

Primary Outcome Measure

Scale for Suicidal Ideation (SSI) [ Time Frame: Six weeks ]

Locations (9)

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