Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205712
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : April 7, 2010
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Psychoses, Substance-Induced
Interventions Drug: Ketamine
Drug: Dexmedetomidine
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine
Hide Arm/Group Description Ketamine without dexmedetomidine Ketamine infusion plus dexmedetomidine
Period Title: Overall Study
Started 20 20
Completed 20 19
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine Total
Hide Arm/Group Description ketamine without dexmedetomidine ketamine infusion plus dexmedetomidine Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
20
 100.0%
20
 100.0%
40
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
11.2  (2.2) 10.9  (2.4) 11  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
7
  35.0%
5
  25.0%
12
  30.0%
Male
13
  65.0%
15
  75.0%
28
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score
Hide Description Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)
Time Frame Before Ketamine, During Ketamine
Hide Outcome Measure Data
Hide Analysis Population Description
Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine
Hide Arm/Group Description:
ketamine without dexmedetomidine
ketamine infusion plus dexmedetomidine
Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: Scale of 0-6
BPRS Positive symptom subscale-before medication 0.00  (0.00) 0.00  (0.00)
BPRS Positive symptom subscale-during medication 1.40  (2.37) 1.00  (1.41)
2.Secondary Outcome
Title Visual Analog Scale (VAS) Pain Intensity
Hide Description Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
Time Frame Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine
Hide Arm/Group Description:
Ketamine without dexmedetomidine
Ketamine infusion with dexmedetomidine
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: Scale of 1-10
VAS Pain-Before Medication 4.72  (1.93) 4.03  (2.38)
VAS Pain-Before Cognitive Testing 2.75  (1.65) 2.89  (1.78)
VAS Pain-After Cognitive Testing 2.61  (1.33) 4.08  (1.85)
VAS Pain-1 Week F/U 1.33  (0.59) 1.76  (1.64)
3.Secondary Outcome
Title Visual Analog Scale (VAS) Anxiety Rating
Hide Description Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
Time Frame Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine
Hide Arm/Group Description:
Ketamine without dexmedetomidine
Ketamine infusion with dexmedetomidine
Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: Scale of 1-10
VAS Anxiety-Before Medication 5.0  (2.43) 5.0  (2.35)
VAS Anxiety-Before Cogntive Testing 1.67  (0.97) 2.53  (1.58)
VAS Anxiety-After Cognitive Testing 1.71  (1.14) 3.00  (2.04)
VAS Anxiety-1 Week Follow Up 1.56  (1.20) 2.06  (1.82)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Alone Ketamine Plus Dexmedetomidine
Hide Arm/Group Description Ketamine without dexmedetomidine Ketamine infusion with dexmedetomidine
All-Cause Mortality
Ketamine Alone Ketamine Plus Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Alone Ketamine Plus Dexmedetomidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Alone Ketamine Plus Dexmedetomidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/20 (95.00%)      19/20 (95.00%)    
Gastrointestinal disorders     
Nausea/Vomiting   5/20 (25.00%)  5 12/20 (60.00%)  12
General disorders     
Trouble Breathing   2/20 (10.00%)  2 1/20 (5.00%)  1
Nervous system disorders     
Sedation   19/20 (95.00%)  19 19/20 (95.00%)  19
headache   3/20 (15.00%)  3 7/20 (35.00%)  7
Dizziness   11/20 (55.00%)  11 11/20 (55.00%)  11
Difficulty Walking   4/20 (20.00%)  4 4/20 (20.00%)  4
Visual Hallucinations   6/20 (30.00%)  6 6/20 (30.00%)  6
Unpleasant Dreams   4/20 (20.00%)  4 2/20 (10.00%)  2
Numbness   15/20 (75.00%)  15 12/20 (60.00%)  12
Indicates events were collected by systematic assessment
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
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00205712     History of Changes
Other Study ID Numbers: NARSAD - Kids
01-0886 ( Other Identifier: Washington University IRB )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: October 27, 2009
Results First Posted: April 7, 2010
Last Update Posted: January 14, 2016