Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Jan 2013
Typical duration for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
April 20, 2017
CompletedApril 20, 2017
April 1, 2017
2.7 years
August 15, 2012
March 2, 2017
April 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
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.
up to 4 months
Secondary Outcomes (1)
HDRS-28 Total
up to 5 months
Study Arms (2)
Ketamine
EXPERIMENTALSubject will receive 6 infusions of ketamine over three weeks.
Placebo
PLACEBO COMPARATORSubjects will receive 6 infusions of normal saline over 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Outpatient with sever treatment resistant depression
- Currently depressed
- Currently under regular psychiatric care
- On an aggressive antidepressant regimen, stable for 4 weeks.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Depression Clinical and Reseach Program - MGH
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cristina Cusin
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina Cusin, M.D.
MGH Department of Psychiatry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor HSM
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
January 1, 2013
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
April 20, 2017
Results First Posted
April 20, 2017
Record last verified: 2017-04