Trial intelligence / Profile preview

Ketamine vs. ECT in Depression

NCT03674671Phase 3

Key facts

Status: Suspended
Start: Oct 2018
Primary completion: Dec 2025
Countries: 1
Sponsor: University of Ottawa
Modality: Small Molecules

Drugs: ketamine
Conditions: major depressive disorder (MDD)bipolar disorder (BD)

Overview

Phase 3, randomised, open-label trial of ketamine in major depressive disorder (MDD) and bipolar disorder (BD) (2 arms), sponsored by University of Ottawa. Primary endpoint: Montgomery-Asberg Depression Rating at 4 weeks. Started Oct 2018; status: suspended.

Design

2 arms

Study design: RandomizedOpen-label

Intravenous Ketamine
0.5mg/kg IV over 40 minutes, thrice weekly.
Electroconvulsive Therapy
Standard ECT thrice weekly as decided by physician.

Who it enrols

Patients aged 18-70 with MDD or Bipolar Depression (MADRS >= 26) who are on an ECT waiting list and willing to be randomized to ketamine or ECT. Must have a BMI < 35 and MOCA >= 24.

Endpoints

Primary

Montgomery-Asberg Depression Rating4 weeks

Secondary

Adverse events7 months
Hospitalization duration4 weeks
Treatment cost7 months
Cognitive function7 months
Neuroimaging biomarkers4 weeks
Molecular biomarkers4 weeks

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