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Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder

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: NCT00181883
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Mania
Intervention Drug: quetiapine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 30
Completed 20
Not Completed 10
Reason Not Completed
Lack of Efficacy             2
Treatment Limiting AEs             3
Withdrawal by Subject             4
Lost to Follow-up             1
Arm/Group Title Quetiapine
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
30
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
5.2  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
5
  16.7%
Male
25
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score
Hide Description The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-14.5  (11.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Quetiapine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Psychiatric disorders   
suicidal ideation * [1]  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
1 subject was terminated due to a serious adverse event possibly related to study medication. The subject had an increase in underlying symptoms of bipolar disorder, experiencing passive suicidal ideation (also present before participation).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.3%
Quetiapine
Affected / at Risk (%) # Events
Total   22/30 (73.33%)    
Gastrointestinal disorders   
constipation *  3/30 (10.00%)  6
diarrhea *  1/30 (3.33%)  1
nausea *  2/30 (6.67%)  2
stomach ache *  4/30 (13.33%)  6
vomiting *  3/30 (10.00%)  4
General disorders   
agitation *  2/30 (6.67%)  2
anxious/figety *  1/30 (3.33%)  1
blurry vision  1/30 (3.33%)  1
cold symptoms *  2/30 (6.67%)  2
daytime sleepiness *  3/30 (10.00%)  5
depressed mood *  1/30 (3.33%)  1
enlarged gland, right side of neck *  1/30 (3.33%)  1
enuresis *  4/30 (13.33%)  6
epistasis (nose bleeding) *  1/30 (3.33%)  1
fever *  2/30 (6.67%)  3
flu *  1/30 (3.33%)  1
headache *  4/30 (13.33%)  8
increased appetite *  4/30 (13.33%)  11
insect bite *  1/30 (3.33%)  1
irritable *  1/30 (3.33%)  2
lethargy *  2/30 (6.67%)  3
minor burn on arm *  1/30 (3.33%)  1
pallor *  1/30 (3.33%)  1
perseveration *  1/30 (3.33%)  1
sedation *  2/30 (6.67%)  4
sleepiness *  8/30 (26.67%)  13
slurred speech *  1/30 (3.33%)  3
somnolence *  1/30 (3.33%)  1
sore throat *  3/30 (10.00%)  5
teary *  1/30 (3.33%)  2
thirsty/dry mouth *  1/30 (3.33%)  1
tiredness *  6/30 (20.00%)  11
Injury, poisoning and procedural complications   
chin/elbow abrasions *  1/30 (3.33%)  1
injury (fall) *  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
congested *  6/30 (20.00%)  8
cough *  2/30 (6.67%)  3
Skin and subcutaneous tissue disorders   
skin irritation *  2/30 (6.67%)  2
sunburn *  1/30 (3.33%)  1
*
Indicates events were collected by non-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
Layout table for Results Point of Contact information
Name/Title: Janet Wozniak, MD
Organization: Massachusetts General Hospital
Phone: 617-503-1038
EMail: jwozniak@partners.org
Layout table for additonal information
Responsible Party: Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181883     History of Changes
Other Study ID Numbers: 2004-P-001509
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: July 19, 2011
Results First Posted: April 6, 2012
Last Update Posted: April 6, 2012