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Ketamine Trial for the Treatment of Depression

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.
 
ClinicalTrials.gov Identifier: NCT02401139
Recruitment Status : Unknown
Verified March 2015 by Colleen Loo, The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date March 27, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Trial for the Treatment of Depression
Official Title  ICMJE Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
Brief Summary This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Unipolar Depression
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Treatment arm
    Ketamine
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo arm
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: March 26, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Individuals will be eligible for enrolment on the basis of:

  • major depressive disorder for at least three months duration
  • an inadequate response to at least 2 adequate antidepressants
  • MADRS ≥ 20

Patients will be excluded on the basis of:

  • History of psychosis
  • History of bipolar disorder
  • Any unstable medical or neurologic condition
  • Any Axis I disorder other than MDD judged to be primary presenting problem
  • Planned major changes to psychotropic medication
  • Significant risk of suicide
  • Planned or probable use of ECT
  • Age under 16 years, or 16-17 years without parental consent
  • Substance abuse or dependence in previous 6 months
  • Any history of abuse of ketamine or phencyclidine
  • Contraindication to the use of ketamine
  • Planned use of ketamine
  • Women of childbearing potential not taking reliable contraception
  • Likely non-compliance with trial treatment
  • Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, 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 NCT02401139
Other Study ID Numbers  ICMJE HREC 15009
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 University of Sydney
Investigators  ICMJE
Principal Investigator: Colleen K Loo, MBBS, MD University of New South Wales
PRS Account The University of New South Wales
Verification Date March 2015

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