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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study has been completed.
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital Identifier:
First received: August 15, 2012
Last updated: April 18, 2017
Last verified: April 2017
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.

Condition Intervention
Major Depressive Disorder Drug: Ketamine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression

Resource links provided by NLM:

Further study details as provided by Cristina Cusin, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 37
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Subject will receive 6 infusions of ketamine over three weeks.
Drug: Ketamine
ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
Placebo Comparator: Placebo
Subjects will receive 6 infusions of normal saline over 3 weeks.
Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01667926

United States, Massachusetts
Depression Clinical and Reseach Program - MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Cristina Cusin, M.D. MGH Department of Psychiatry
  More Information

Responsible Party: Cristina Cusin, MD, Instructor HSM, Massachusetts General Hospital Identifier: NCT01667926     History of Changes
Other Study ID Numbers: 2012-P-001042
Study First Received: August 15, 2012
Results First Received: March 2, 2017
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 25, 2017