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Ketamine As an Adjunctive Therapy for Major Depression (2)

NCT04939649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-02-13

No results posted yet for this study

Summary

Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.

Conditions

Interventions

DRUG

Ketamine

A sub-anaesthetic dose of ketamine will be administered for up to a four-week course of twice-weekly infusions.

DRUG

Midazolam

A sub-anaesthetic dose of midazolam will be administered for up to a four-week course of twice-weekly infusions.

Sponsors & Collaborators

  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Declan M McLoughlin, PhD · University of Dublin, Trinity College and St Patrick's Mental Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2024-04-18
Completion
2024-08-12

Countries

  • Ireland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939649 on ClinicalTrials.gov