A Study of Ketamine as an Antidepressant

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by The University of New South Wales
Sponsor:
Collaborator:
Wesley Hospital, Kogarah
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01441505
First received: September 16, 2011
Last updated: February 20, 2013
Last verified: February 2013

September 16, 2011
February 20, 2013
September 2011
December 2014   (final data collection date for primary outcome measure)
Change from baseline on depression rating scales [ Time Frame: Before, 4 hours after, and 24 hours after ketamine session ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01441505 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Ketamine as an Antidepressant
A Study of Ketamine as an Antidepressant

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Episode
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Angelo Alonzo 61 02 9382 3720 TMSandDCS@unsw.edu.au
Australia
 
NCT01441505
HREC 10409
No
Colleen Loo, The University of New South Wales
The University of New South Wales
Wesley Hospital, Kogarah
Principal Investigator: Colleen K Loo, MB BS FRANZCP MD University of New South Wales
The University of New South Wales
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP