Intranasal Ketamine in Treatment-Resistant Depression

Brief Summary

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Intervention / Treatment

  • Ketamine (DRUG)
    A single dose of intranasal ketamine up to 50 mg
  • Placebo (DRUG)
    Single dose of saline intranasal

Condition or Disease

  • Major Depressive Disorder

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 65 Years
    Enrollment: 20 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Oct 01, 2011
    Primary Completion: Oct 01, 2014 ACTUAL
    Completion Date: Oct 01, 2014 ACTUAL
    Study First Posted: Feb 25, 2011 ESTIMATED
    Results First Posted: Feb 08, 2017 ESTIMATED
    Last Updated: Dec 16, 2016

    Sponsors / Collaborators

    Lead Sponsor: James Murrough
    Responsible Party: James Murrough

    Participant Groups

    • Subjects randomized to this arm will receive the active study medication, intranasal ketamine.

    • Subjects randomized to this arm will receive intranasal saline.

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. Male or female patients, 21-65 years;
    2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
    3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
    4. Current depressive episode;
    5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
    6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
    7. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
    8. Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

    Exclusion Criteria:

    1. Women who plan to become pregnant, are pregnant or are breast-feeding;
    2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
    3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
    4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
    5. Drug or alcohol abuse or dependence within the preceding 6 months;
    6. Lifetime abuse or dependence on ketamine or phencyclidine;
    7. Patients judged by study investigator to be at high risk for suicide.
    8. Previous participation in a ketamine study at Mount Sinai

    Primary Outcomes
    • Number of patients meeting response criteria of \>=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.

    Secondary Outcomes
    • This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.

    More Details

    NCT Number: NCT01304147
    Other IDs: GCO 11-0492
    Study URL: https://clinicaltrials.gov/study/NCT01304147
    Last updated: Sep 29, 2023