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A Study of Ketamine as an Antidepressant

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Wesley Mission
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE September 16, 2011
First Posted Date  ICMJE September 27, 2011
Last Update Posted Date February 22, 2013
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2011)
Change from baseline on depression rating scales [ Time Frame: Before, 4 hours after, and 24 hours after ketamine session ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2011)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ketamine as an Antidepressant
Official Title  ICMJE A Study of Ketamine as an Antidepressant
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Episode
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 3, 2011)
42
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2011)
28
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01441505
Other Study ID Numbers  ICMJE HREC 10409
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colleen Loo, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Wesley Mission
Investigators  ICMJE
Principal Investigator: Colleen K Loo, MB BS FRANZCP MD University of New South Wales
PRS Account The University of New South Wales
Verification Date February 2013

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