Ketamine Trial for the Treatment of Depression

Ketamine

Brief Summary

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

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Placebo (DRUG)
    N/A

Condition or Disease

  • Unipolar Depression

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 16 Years and older   (Child, Adult, Older Adult)
    Enrollment: 10 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Mar 01, 2015 ACTUAL
    Primary Completion: Jul 01, 2015 ACTUAL
    Completion Date: Sep 01, 2015 ACTUAL
    Study First Posted: Mar 27, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 28, 2023

    Sponsors / Collaborators

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

    Location

    New South Wales, Australia
    Sydney, New South Wales, Australia
    Camperdown, New South Wales, Australia

    Participant Groups

    • Ketamine

    • Placebo

    Eligibility Criteria

    Sex: All
    Minimum Age: 16
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Montgomery Asberg Depression Rating Scale for Depression (MADRS) 4 weeks

    More Details

    NCT Number: NCT02401139
    Other IDs: HREC 15009
    Study URL: https://clinicaltrials.gov/study/NCT02401139
    Last updated: Sep 29, 2023