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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667926
First Posted: August 17, 2012
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667926


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

Responsible Party: Cristina Cusin, MD, Instructor HSM, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01667926     History of Changes
Other Study ID Numbers: 2012-P-001042
First Submitted: August 15, 2012
First Posted: August 17, 2012
Results First Submitted: March 2, 2017
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action