Ketamine Infusion for Treatment-resistant Major Depressive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01582945
First received: April 17, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention
Major Depressive Disorder
Drug: Ketamine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation

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: Weekly for total duration of 4 months ] [ Designated as safety issue: No ]
    Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks


Secondary Outcome Measures:
  • Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: Weekly for total duration of 4 months ] [ Designated as safety issue: Yes ]
    Patients will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01582945     History of Changes
Other Study ID Numbers: 2010-P-002800
Study First Received: April 17, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 18, 2014