Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Ketamine

Brief Summary

Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.

Intervention / Treatment

  • Ketamine (DRUG)
    ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
  • Placebo (DRUG)
    N/A

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: 37 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2013
    Primary Completion: Oct 01, 2015 ACTUAL
    Completion Date: Nov 01, 2015 ACTUAL
    Study First Posted: Aug 17, 2012 ESTIMATED
    Results First Posted: Apr 20, 2017 ACTUAL
    Last Updated: Apr 18, 2017

    Sponsors / Collaborators

    Lead Sponsor: Massachusetts General Hospital
    Responsible Party: N/A

    Location

    Boston, Massachusetts, USA

    Participant Groups

    • Subject will receive 6 infusions of ketamine over three weeks.

    • Subjects will receive 6 infusions of normal saline over 3 weeks.

    Eligibility Criteria

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

    Inclusion Criteria:

    * Outpatient with sever treatment resistant depression
    * Currently depressed
    * Currently under regular psychiatric care
    * On an aggressive antidepressant regimen, stable for 4 weeks.

    Exclusion Criteria:

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

    Primary Outcomes

    • The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.

    Secondary Outcomes

    • Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.

    More Details

    NCT Number: NCT01667926
    Other IDs: 2012-P-001042
    Study URL: https://clinicaltrials.gov/study/NCT01667926
    Last updated: Sep 29, 2023