Optimization of IV Ketamine for Treatment Resistant Depression

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00768430
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.
No text entered.

Reporting Groups
  Description
Ketamine Ketamine
Midazolam Midazolam
Total Total of all reporting groups

Baseline Measures
    Ketamine     Midazolam     Total  
Number of Participants  
[units: participants]
  48     25     73  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 12.8     42.7  ± 11.6     44.8  ± 12.2  
Gender  
[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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