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
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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
  Description
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  
NOT COMPLETED     1     0  

Period 2:   7 Day Endpoint
    Ketamine     Midazolam  
STARTED     47     25  
COMPLETED     45     22  
NOT COMPLETED     2     3  
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.
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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Ketamine Ketamine
Midazolam Midazolam

Other Adverse Events
    Ketamine     Midazolam  
Total, other (not including serious) adverse events      
# participants affected / at risk     47/47     25/25  
Gastrointestinal disorders      
Nausea    
# participants affected / at risk     16/47 (34.04%)     3/25 (12.00%)  
Dry Mouth    
# participants affected / at risk     12/47 (25.53%)     4/25 (16.00%)  
Nervous system disorders      
Headache    
# participants affected / at risk     15/47 (31.91%)     5/25 (20.00%)  
Dizziness on standing    
# participants affected / at risk     10/47 (21.28%)     2/25 (8.00%)  
Poor Concentration    
# participants affected / at risk     19/47 (40.43%)     12/25 (48.00%)  
Events were collected by systematic assessment



  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.


  More Information