Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Brief Summary

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD). This is an open-label study (pilot).

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Condition or Disease

  • Major Depressive Disorder

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 14 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 01, 2012
    Primary Completion: Sep 01, 2014 ACTUAL
    Completion Date: Dec 01, 2014 ACTUAL
    Study First Posted: Apr 23, 2012 ESTIMATED
    Results First Posted: Apr 20, 2017 ACTUAL
    Last Updated: Apr 18, 2017

    Sponsors / Collaborators

    Responsible Party: N/A

    Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

    Total duration of the study is 5 months.

    Participant Groups

    • Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks

    Eligibility Criteria

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

    Inclusion Criteria:

    * Outpatients with severe treatment-resistant MDD
    * Currently depressed
    * Currently under regular psychiatric care
    * On an aggressive antidepressant regimen, stable for 4 weeks

    Exclusion Criteria:

    * No history of other major psychiatric illnesses, including bipolar disorder
    * No history of psychosis
    * No history of drug abuse
    * No major medical illness or unstable medical conditions

    Primary Outcomes
    • Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.

    More Details

    NCT Number: NCT01582945
    Other IDs: 2010-P-002800
    Study URL: https://clinicaltrials.gov/study/NCT01582945
    Last updated: Sep 29, 2023