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Ketamine Infusion for Treatment-resistant Major Depressive Disorder

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.
ClinicalTrials.gov Identifier: NCT01582945
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).

This is an open-label study (pilot).


Condition or disease Intervention/treatment
Major Depressive Disorder Drug: Ketamine

Detailed Description:

Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

Total duration of the study is 5 months.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
Study Start Date : April 2012
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ketamine IV
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Drug: Ketamine
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen


Outcome Measures

Primary Outcome Measures :
  1. Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) [ Time Frame: Weekly for total duration of 4 months ]
    Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.


Eligibility Criteria

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:

  • Outpatients with severe treatment-resistant MDD
  • Currently depressed
  • Currently under regular psychiatric care
  • On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

  • No history of other major psychiatric illnesses, including bipolar disorder
  • No history of psychosis
  • No history of drug abuse
  • No major medical illness or unstable medical conditions
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): NCT01582945


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

Publications:
Responsible Party: Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01582945     History of Changes
Other Study ID Numbers: 2010-P-002800
First Posted: April 23, 2012    Key Record Dates
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Cristina Cusin, MD, Massachusetts General Hospital:
Treatment resistant
suicidal ideation
major depressive disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Suicidal Ideation
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Suicide
Self-Injurious Behavior
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