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Ketamine as an Adjunctive Therapy for Major Depression

NCT03256162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-01-18

Study results available
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Summary

Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Conditions

Interventions

DRUG

Ketamine

A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.

DRUG

Midazolam

A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.

Sponsors & Collaborators

  • St Patrick's Hospital, Ireland

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2018-09-21
Completion
2018-09-21

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 NCT03256162 on ClinicalTrials.gov