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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01667926
First received: August 15, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes

August 15, 2012
January 11, 2013
January 2013
October 2014   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale - 28 Items [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
Subjects will be assessed with HAM-D
Same as current
Complete list of historical versions of study NCT01667926 on ClinicalTrials.gov Archive Site
Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]
Subjects will be monitored for emergence of side effects weekly for the first 8 weeks and then every two weeks for 8 weeks.
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Active, not recruiting
30
October 2014
October 2014   (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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01667926
2012-P-001042
Yes
Cristina Cusin, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Cristina Cusin, M.D. MGH Department of Psychiatry
Massachusetts General Hospital
January 2013

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