A Study of Ketamine as an Antidepressant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441505
Recruitment Status : Unknown
Verified February 2013 by Colleen Loo, The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : September 27, 2011
Last Update Posted : February 22, 2013
Wesley Hospital, Kogarah
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Episode Drug: Ketamine Drug: Saline or Midazolam (active placebo) Phase 2

Detailed Description:

This clinical study consists of two phases. In Phase I, participants will receive variable doses of intravenous, intramuscular, or subcutaneous ketamine (0.1-0.5mg/kg) or placebo (saline, or 0.01mg/kg midazolam) weekly for up to 6 consecutive weeks. Prior to receiving ketamine/placebo, participants' mood and psychiatric symptoms will be assessed. Once they have received their treatment, mood, psychiatric side effects, ketamine blood levels, heart rate, blood pressure and biomarkers will be assessed. Mood and cognitive performance be assessed again after 4 hours. Finally, mood will also be assessed the next day.

Some participants may be eligible to continue to Phase II. In this phase, participants will receive doses of ketamine approximately weekly for up to 6 months. During this phase, participants' mood, psychiatric, biomarkers and cognitive outcomes will be assessed.

The purpose of the trial is to investigate the antidepressant and safety effects of using ketamine as a treatment in depression.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Ketamine as an Antidepressant
Study Start Date : September 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Ketamine
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Change from baseline on depression rating scales [ Time Frame: Before, 4 hours after, and 24 hours after ketamine session ]

Secondary Outcome Measures :
  1. Psychiatric side effects (BPRS, CADSS) and memory tests [ Time Frame: Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441505

Contact: Angelo Alonzo 61 02 9382 3720

Australia, New South Wales
Wesley Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
The University of New South Wales
Wesley Hospital, Kogarah
Principal Investigator: Colleen K Loo, MB BS FRANZCP MD University of New South Wales

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Colleen Loo, Associate Professor, The University of New South Wales Identifier: NCT01441505     History of Changes
Other Study ID Numbers: HREC 10409
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents