Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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
Sites / Locations
- Depression Clinical and Reseach Program - MGH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
Subject will receive 6 infusions of ketamine over three weeks.
Subjects will receive 6 infusions of normal saline over 3 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
HDRS-28 Total
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.
Full Information
NCT ID
NCT01667926
First Posted
August 15, 2012
Last Updated
April 18, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01667926
Brief Title
Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Official Title
Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Subject will receive 6 infusions of ketamine over three weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive 6 infusions of normal saline over 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
Description
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.
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
HDRS-28 Total
Description
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.
Time Frame
up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Cusin, M.D.
Organizational Affiliation
MGH Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Clinical and Reseach Program - MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
We'll reach out to this number within 24 hrs