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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01667926
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 15, 2012
First Posted Date  ICMJE August 17, 2012
Results First Submitted Date  ICMJE March 2, 2017
Results First Posted Date  ICMJE April 20, 2017
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) [ Time Frame: up to 4 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
Hamilton Depression Rating Scale - 28 Items [ Time Frame: up to 4 months ]
Subjects will be assessed with HAM-D
Change History Complete list of historical versions of study NCT01667926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
HDRS-28 Total [ Time Frame: up to 5 months ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 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 and then every two weeks for 8 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Official Title  ICMJE Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Subject will receive 6 infusions of ketamine over three weeks.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Subjects will receive 6 infusions of normal saline over 3 weeks.
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
30
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01667926
Other Study ID Numbers  ICMJE 2012-P-001042
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 April 2017

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