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Unknown statusPhase 2

A Study of Ketamine as an Antidepressant

NCT01441505 · The University of New South Wales

Closed to entry
Status
Not accepting participants
Phase 2
Phase
42
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Recently, interest has emerged in the use of ketamine as an antidepressant. Recent placebo-controlled clinical trials administering a single dose and an open label trial giving repeated doses shown that ketamine is markedly superior to placebo at reducing depression, including in treatment-resistant patients, and that its antidepressant effects have a very rapid onset. This clinical study consists of two phases. In Phase I, participants who satisfy inclusion criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II, they will receive repeated sessions of ketamine at variable doses over three weeks. During both phases, mood, psychiatric, and neuropsychological outcomes will be measured.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change from baseline on depression rating scales

    Measured over Before, 4 hours after, and 24 hours after ketamine session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Satisfy DSM-IV-TR criteria for Major Depressive Episode * 18 years or over * Able to give informed consent Exclusion Criteria: * Diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms * Known sensitivity or contraindication to ketamine * Recent drug abuse * Pregnant

Where

1 study site

FacilityCityRegionCountry
Wesley HospitalKogarahNew South WalesAustralia

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01441505 on ClinicalTrials.gov →

Last updated in the registry 2013-02-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from The University of New South Wales →