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Ketamine Trial for the Treatment of Depression

Primary Purpose

Unipolar Depression

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brain & Mind Research Institute (BMRI), University of Sydney
  • Black Dog Institute, University of New South Wales

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment arm

Placebo arm

Arm Description

Ketamine

Placebo

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Full Information

First Posted
March 24, 2015
Last Updated
March 28, 2023
Sponsor
The University of New South Wales
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02401139
Brief Title
Ketamine Trial for the Treatment of Depression
Official Title
Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
Collaborators
University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
Ketamine
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen K Loo, MBBS, MD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain & Mind Research Institute (BMRI), University of Sydney
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Black Dog Institute, University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

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Ketamine Trial for the Treatment of Depression

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