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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01667926
First received: August 15, 2012
Last updated: April 18, 2017
Last verified: April 2017
August 15, 2012
April 18, 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 ClinicalTrials.gov 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.
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01667926
2012-P-001042
Yes
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