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Trial record 39 of 215 for:    Lamotrigine

Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00181844
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: lamotrigine
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine
Hide Arm/Group Description [Not Specified]
Period Title: Signed Consent
Started 51
Completed 39
Not Completed 12
Reason Not Completed
Withdrawal by Subject             5
Did not meet entrance criteria             7
Period Title: Exposed to Study Medication
Started 39
Completed 22
Not Completed 17
Reason Not Completed
Adverse Event             10
Lack of Efficacy             2
Non-compliance             2
Withdrawal by Subject             1
Difficulty meeting study schedule             2
Arm/Group Title Lamotrigine
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
39
 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 39 participants
10.8  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
15
  38.5%
Male
24
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)
Hide Description Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-14.9  (9.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Lamotrigine
Affected / at Risk (%) # Events
Total   34/39 (87.18%)    
Cardiac disorders   
Palpitations *  1/39 (2.56%)  1
Ear and labyrinth disorders   
Dizziness *  4/39 (10.26%)  5
Ear pain *  3/39 (7.69%)  4
Eye disorders   
Eye irritation *  2/39 (5.13%)  2
Gastrointestinal disorders   
Acid reflux *  1/39 (2.56%)  5
Appetite loss *  3/39 (7.69%)  4
Constipation *  1/39 (2.56%)  1
Diarrhea *  2/39 (5.13%)  2
Dyspepsia *  3/39 (7.69%)  5
GERD vomiting *  1/39 (2.56%)  2
Nausea *  4/39 (10.26%)  10
Stomach ache *  7/39 (17.95%)  15
Vomiting *  8/39 (20.51%)  13
General disorders   
Backache *  1/39 (2.56%)  1
Bruising *  1/39 (2.56%)  1
Chest pain *  2/39 (5.13%)  2
Cold *  3/39 (7.69%)  3
Fatigue *  5/39 (12.82%)  9
Fever *  5/39 (12.82%)  6
Headache *  15/39 (38.46%)  37
Increased appetite *  1/39 (2.56%)  2
Insomnia *  3/39 (7.69%)  3
Jitteriness *  2/39 (5.13%)  2
Lethargy *  2/39 (5.13%)  8
Loss of voluntary movement *  2/39 (5.13%)  2
Malaise *  1/39 (2.56%)  1
Nasal congestion *  6/39 (15.38%)  7
Nosebleed *  1/39 (2.56%)  1
Rhinorhea *  4/39 (10.26%)  5
Shakiness *  2/39 (5.13%)  2
Sore throat *  7/39 (17.95%)  8
Temper tantrum *  2/39 (5.13%)  2
Tooth pain *  6/39 (15.38%)  8
Unsteady *  2/39 (5.13%)  2
Infections and infestations   
Ear infection *  3/39 (7.69%)  3
Sinus infection *  1/39 (2.56%)  1
Upper respiratory infection *  1/39 (2.56%)  1
Injury, poisoning and procedural complications   
Injury *  11/39 (28.21%)  17
Poison Ivy *  1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders   
Hip dysplasia *  2/39 (5.13%)  2
Psychiatric disorders   
More manic *  1/39 (2.56%)  1
Panic attacks *  2/39 (5.13%)  4
Reproductive system and breast disorders   
Menstrual cramps *  1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough *  5/39 (12.82%)  9
Wheezing *  1/39 (2.56%)  2
Skin and subcutaneous tissue disorders   
Itching *  3/39 (7.69%)  3
Rashes *  7/39 (17.95%) 
Contact dermatitis *  2/39 (5.13%) 
Sunburn *  2/39 (5.13%) 
Miscellaneous other skin lesions *  4/39 (10.26%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
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: NCT00181844     History of Changes
Other Study ID Numbers: 2004-P-001419
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: July 27, 2011
Results First Posted: April 6, 2012
Last Update Posted: April 6, 2012