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Optimization of IV Ketamine for Treatment Resistant Depression

This study has been completed.
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine Identifier:
First received: October 7, 2008
Last updated: December 27, 2013
Last verified: December 2013
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder (MDD)
Treatment Resistant Depression (TRD)
Interventions: Drug: Ketamine
Drug: Midazolam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study enrolled patients at two academic sites, Baylor College of Medicine and Icahn School of Medicine at Mount Sinai, between November 2010 and August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The protocol required patients to be drug free prior to the infusion, for at at least 1 week (4 for fluoxetine) for those taking other medications. Randomly assigned in a 2:1 ratio, the patients received a single intravenous infusion of ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) infused over 40 minutes.

Reporting Groups
Ketamine single infusion of 0.5mg/kg of Ketamine HCL
Midazolam single infusion of midazolam being used as an active control for the study

Participant Flow for 2 periods

Period 1:   24 Hour Endpoint
    Ketamine   Midazolam
STARTED   48   25 
COMPLETED   47   25 

Period 2:   7 Day Endpoint
    Ketamine   Midazolam
STARTED   47   25 
COMPLETED   45   22 
Withdrawal by Subject                2                3 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Ketamine Ketamine
Midazolam Midazolam
Total Total of all reporting groups

Baseline Measures
    Ketamine   Midazolam   Total
Overall Participants 
[units: participants]
 48   25   73 
[units: years]
Mean (Standard Deviation)
 46.9  (12.8)   42.7  (11.6)   44.8  (12.2) 
[units: participants]
Female   27   11   38 
Male   21   14   35 
Region of Enrollment 
[units: participants]
United States   48   25   73 

  Outcome Measures

1.  Primary:   MADRS   [ Time Frame: 24 hours post-infusion ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

  More Information