Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667926
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

August 15, 2012
August 17, 2012
March 2, 2017
April 20, 2017
April 20, 2017
January 2013
October 2015   (Final data collection date for primary outcome measure)
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.
Hamilton Depression Rating Scale - 28 Items [ Time Frame: up to 4 months ]
Subjects will be assessed with HAM-D
Complete list of historical versions of study NCT01667926 on Archive Site
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.
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.
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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Ketamine
    ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Cristina Cusin, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Cristina Cusin, M.D. MGH Department of Psychiatry
Massachusetts General Hospital
April 2017

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