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A Study of Ketamine as an Antidepressant

NCT01441505 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-02-22

No results posted yet for this study

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.

Conditions

  • Major Depressive Episode

Interventions

DRUG

Ketamine

Ketamine IV, IM, or SC will be administered in Phase I and II

DRUG

Saline or Midazolam (active placebo)

Saline, or midazolam 0.01mg/kg will be administered in Phase I

Sponsors & Collaborators

  • Wesley Mission

    collaborator OTHER

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Colleen K Loo, MB BS FRANZCP MD · University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01441505 on ClinicalTrials.gov