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Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01613820
Recruitment Status : Withdrawn (Lack of funding)
First Posted : June 7, 2012
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 31, 2012
First Posted Date  ICMJE June 7, 2012
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
Hamilton Depression Rating Scale - 28 items [ Time Frame: up to 4 months ]
Subjects will be assessed with HAMD-28
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: up to 4 months ]
Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder
Official Title  ICMJE Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study
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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
  • Drug: Scopolamine
    Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Study Arms  ICMJE
  • Experimental: Ketamine plus placebo
    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.
    Intervention: Drug: Ketamine
  • Experimental: Scopolamine plus placebo
    Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).
    Intervention: Drug: Scopolamine
  • Experimental: Ketamine plus scopolamine
    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.
    Interventions:
    • Drug: Ketamine
    • Drug: Scopolamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 15, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2012)
15
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613820
Other Study ID Numbers  ICMJE 2012-P-000624
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristina Cusin, M.D. MGH Department of Psychiatry
PRS Account Massachusetts General Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP