Ketamine and Scopolamine Infusions 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. Scopolamine infusions produced also a significant improvement in depression that was sustained over time. We therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.

Intervention / Treatment

  • Ketamine (DRUG)
    ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
  • Scopolamine (DRUG)
    Scopolamine 2ug/kg over 15 minutes 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    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Sep 01, 2015 ACTUAL
    Primary Completion: Feb 01, 2017 ACTUAL
    Completion Date: Feb 01, 2017 ACTUAL
    Study First Posted: Jun 07, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 15, 2018

    Sponsors / Collaborators

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

    Location

    Boston, Massachusetts, USA

    Patients will undergo two weeks of prospective observation, they will then receive IV infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. The schedule of administration will be twice a week of three weeks. After this phase the subject will be followed with assessments every two weeks for three months.

    Participant Groups

    • Subjects assigned to this paradigm will receive a 15 minute infusion of normal saline (placebo) followed by IV ketamine at 0.25mg/kg over 45 minutes twice a week for 3 weeks.

    • Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).

    • Subject will receive an IV scopolamine infusion at a dose of 2ug/kg over 15 minutes, followed by an IV infusion of ketamine at a dose of 0.25mg/kg over 45 minutes.

    Eligibility Criteria

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

    Inclusion Criteria:

    * Outpatients 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 illnesses, including bipolar disorder
    * No history of psychosis
    * No history of drug abuse
    * No major medical illness or unstable medical condition.

    Primary Outcomes

    • Subjects will be assessed with HAMD-28

    Secondary Outcomes

    • Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.

    More Details

    NCT Number: NCT01613820
    Other IDs: 2012-P-000624
    Study URL: https://clinicaltrials.gov/study/NCT01613820
    Last updated: Sep 29, 2023