A Study of Ketamine as an Antidepressant

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of New South Wales
• Collaborators: Wesley Hospital, Kogarah; Wesley Mission
• Treatments: Antidepressive Agents; Ketamine; Midazolam

Criteria

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