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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):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 17, 2012
First Posted Date  ICMJE April 23, 2012
Results First Submitted Date  ICMJE March 2, 2017
Results First Posted Date  ICMJE April 20, 2017
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Hamilton Depression Rating Scale -28 items [ 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: Weekly for total duration of 4 months ]
Patients will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Official Title  ICMJE N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
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).

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Ketamine
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Study Arms  ICMJE Experimental: Ketamine IV
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
20
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582945
Other Study ID Numbers  ICMJE 2010-P-002800
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristina Cusin, MD MGH Department of Psychiatry
PRS Account Massachusetts General Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP