Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Ketamine

Brief Summary

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A

Condition or Disease

  • Depressive Disorder, Treatment-Resistant

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 20 (ESTIMATED)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: May 01, 2014
    Primary Completion: Dec 01, 2017 ESTIMATED
    Completion Date: Aug 31, 2020
    Study First Posted: Nov 20, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 20, 2016

    Sponsors / Collaborators

    Lead Sponsor: National Institute of Neurology and Neurosurgery, Mexico
    Responsible Party: N/A

    Location

    Distrito Federal, Mexico
    Mexico City, Distrito Federal, Mexico

    The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).

    Participant Groups

    • Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.

    Eligibility Criteria

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

    Inclusion Criteria:

    * Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
    * Acceptance of participation via the informed consent

    Exclusion Criteria:

    * Psychiatric comorbidity (except anxiety related disorders)
    * Substance abuse or dependence in the previous 3 months
    * Evidence of structural abnormalities in brain imaging
    * Pregnancy
    * Previous hypersensitivity to ketamine
    * Heart failure or insufficiency
    * Familial or personal history of psychosis
    * Glaucoma
    * Major neurological disease
    * Uncontrolled systemic arterial hypertension
    * MRI contraindications
    * Non-acceptance of participation via informed consent

    Primary Outcomes
    • Hamilton Depression Rating Scale (HDRS) Score Change from baseline HDRS Score at 24 hours
    Secondary Outcomes

    • Glutamate concentrations in the pregenual cingulate cortex measured by Magnetic Resonance Spectroscopy

    • Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA

    More Details

    NCT Number: NCT02610712
    Other IDs: 63/13
    Study URL: https://clinicaltrials.gov/study/NCT02610712
    Last updated: Sep 29, 2023