A Study of Ketamine as an Antidepressant

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine IV, IM, or SC will be administered in Phase I and II
  • Saline or Midazolam (active placebo) (DRUG)
    Saline, or midazolam 0.01mg/kg will be administered in Phase I

Condition or Disease

  • Major Depressive Episode

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 42 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2011
    Primary Completion: Dec 01, 2014 ESTIMATED
    Completion Date: Dec 01, 2014 ESTIMATED
    Study First Posted: Sep 27, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 20, 2013

    Sponsors / Collaborators

    Lead Sponsor: The University of New South Wales
    Responsible Party: N/A

    Location

    New South Wales, Australia
    Kogarah, New South Wales, Australia

    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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Change from baseline on depression rating scales Before, 4 hours after, and 24 hours after ketamine session
    Secondary Outcomes
    • Psychiatric side effects (BPRS, CADSS) and memory tests Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases.

    More Details

    NCT Number: NCT01441505
    Other IDs: HREC 10409
    Study URL: https://clinicaltrials.gov/study/NCT01441505
    Last updated: Sep 29, 2023