Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Massachusetts General Hospital
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital Identifier:
First received: August 15, 2012
Last updated: June 1, 2015
Last verified: June 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale - 28 Items [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
    Subjects will be assessed with HAM-D

Secondary Outcome Measures:
  • Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: up to 5 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.

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: October 2016
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01667926

Contact: Cristina Cusin, M.D. 1-617-726-6421

United States, Massachusetts
Depression Clinical and Reseach Program - MGH Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cristina Cusin, M.D.    617-726-6421   
Principal Investigator: Cristina Cusin, M.D.         
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
Last Updated: June 1, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 30, 2016