Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Ketamine

Brief Summary

The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.

Intervention / Treatment

  • Ketamine (DRUG)
    1mg/kg, 6 applications over 2 weeks
  • Midazolam Hydrochloride (DRUG)
    0.03mg/kg, 6 applications over 2 weeks

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 to 64 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Apr 24, 2017 ACTUAL
    Primary Completion: Dec 01, 2020 ESTIMATED
    Completion Date: Dec 01, 2020 ESTIMATED
    Study First Posted: Dec 14, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 30, 2019

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Vienna
    Responsible Party: N/A

    Location

    Vienna, Austria

    Participant Groups

    • Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.

    • Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 64
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
    * Hamilton depression rating scale score ≥ 19
    * Willingness and competence to sign the informed consent form
    * Stable psychopharmacological treatment for 10 days (except benzodiazepines)

    Exclusion Criteria:

    * Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
    * Prior use of ketamine
    * Pregnancy/Breast feeding
    * Instable arterial hypertension \>170/110mmHg
    * Hepatic dysfunction
    * Hyperthyreosis
    * History of glaucoma
    * Neurodegenerative disorders
    * Any unstable medical illness
    * History of substance abuse within the past 12 months
    * History of psychosis
    * Failure to comply with the study protocol or to follow the instructions of the investigating team
    * Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.

    Primary Outcomes
    • Montgomery-Åsberg Depression Rating Scale (MADRS) 1 week
    Secondary Outcomes
    • Clinician Administered Dissociative States Scale (CADSS) 2 weeks
    • Hamilton Depression Rating Scale 1 week

    More Details

    NCT Number: NCT02992496
    Other IDs: v1.2_20161024
    Study URL: https://clinicaltrials.gov/study/NCT02992496
    Last updated: Sep 29, 2023