Intra-nasal vs. Intra-venous Ketamine Administration

Ketamine

Brief Summary

The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.

Intervention / Treatment

  • Placebo (DRUG)
    Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
  • Ketamine (1st phase) (DRUG)
    Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
  • Ketamine (2st phase) (DRUG)
    Patients failing to achieve response (\<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 45 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2016
    Primary Completion: May 01, 2020 ACTUAL
    Completion Date: May 01, 2020 ACTUAL
    Study First Posted: Jan 01, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 27, 2020

    Sponsors / Collaborators

    Lead Sponsor: Shalvata Mental Health Center
    Responsible Party: N/A

    Location

    Hod Hasharon, Israel
    Shalvata MHC, Hod Hasharon, Israel

    Participant Groups

    • Will receive IV Ketamine, along with IN placebo.

    • Will receive IN Ketamine, along with IV placebo.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. Age 18-65
    2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
    3. MADRS score \> 20
    4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.

    Exclusion Criteria:

    1. Active or past psychotic disorder, including a history of psychotic affective state
    2. Mental Retardation or Autistic Spectrum Disorder
    3. Prominent personality disorder
    4. Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition.
    5. Chronic nasal congestion
    6. Active or recent drug or alcohol abuse
    7. Substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission.

    Primary Outcomes
    • MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline 15 weeks
    Secondary Outcomes
    • Ratio of subjects achieving remission 15 weeks
    • Ratio of subjects achieving Response 15 weeks

    • The rate of effect decline, as measured by MADRS Questionnaire

    • Adverse side effects reported by subjects, as reported in side effects questionnaire

    More Details

    NCT Number: NCT02644629
    Other IDs: SHA-15-0019
    Study URL: https://clinicaltrials.gov/study/NCT02644629
    Last updated: Sep 29, 2023