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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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 15, 2012
Last Updated
April 18, 2017
Sponsor
Massachusetts General Hospital
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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

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