Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00205712
First received: September 13, 2005
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: October 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Psychoses, Substance-Induced
Interventions: Drug: Ketamine
Drug: Dexmedetomidine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ketamine Alone Ketamine without dexmedetomidine
Ketamine Plus Dexmedetomidine Ketamine infusion plus dexmedetomidine

Participant Flow:   Overall Study
    Ketamine Alone     Ketamine Plus Dexmedetomidine  
STARTED     20     20  
COMPLETED     20     19  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
  Description
Ketamine Alone ketamine without dexmedetomidine
Ketamine Plus Dexmedetomidine ketamine infusion plus dexmedetomidine
Total Total of all reporting groups

Baseline Measures
    Ketamine Alone     Ketamine Plus Dexmedetomidine     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     20     20     40  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.2  ± 2.2     10.9  ± 2.4     11  ± 2.3  
Gender  
[units: participants]
     
Female     7     5     12  
Male     13     15     28  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score   [ Time Frame: Before Ketamine, During Ketamine ]

2.  Secondary:   Visual Analog Scale (VAS) Pain Intensity   [ Time Frame: Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up ]

3.  Secondary:   Visual Analog Scale (VAS) Anxiety Rating   [ Time Frame: Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Newcomer, MD
Organization: Washington University School of Medicine
phone: 314-362-3153
e-mail: newcomerj@wustl.edu


No publications provided


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00205712     History of Changes
Other Study ID Numbers: NARSAD - Kids, 01-0886
Study First Received: September 13, 2005
Results First Received: October 27, 2009
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration