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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

  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
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of our trial include stringent enrollment criteria due to concerns about ketamine’s psychoactive effects and abuse liability. A proportion of screened patients (17.2%) refused or were unable to tolerate psychotropic washout.

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