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Lamotrigine Monotherapy in Pediatric Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00176228
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mani Pavuluri, University of Illinois at Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Intervention Drug: Lamotrigine
Enrollment 48
Recruitment Details In the University of Illinois. The duration of the trial is 14 weeks, with initial 8 weeks of dose titration, followed by 6 weeks of administering the full dose.
Pre-assignment Details To participate, subjects were required to consent to being washed out of their current medications at study entry. The washout period consisted of tapering their previous medications over one week prior to study entry except for those who received aripiprazole or fluoxetine who required a 4-week washout period.
Arm/Group Title Lamotrigine
Hide Arm/Group Description upto 200 mg
Period Title: Overall Study
Started 48 [1]
Completed 46 [2]
Not Completed 2
[1]
When study began
[2]
Study ended
Arm/Group Title Lamotrigine
Hide Arm/Group Description upto 200 mg
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
48
 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 48 participants
13.3  (2.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
27
  56.3%
Male
21
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Young Mania Rating Scale (YMRS),
Hide Description This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient’s subjective report of his or her condition over the previous forty-eight hours and the clinician’s behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.
Time Frame Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Effectiveness on YMRS (Mania Measure)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 19.61  (8.94)
8 week point 7.06  (6.28)
14 week point 5.68  (7.08)
2.Secondary Outcome
Title Child Depression Rating Scale (CDRS-R)
Hide Description Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.
Time Frame weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine
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Lamotrigine: Response on CDRS-R
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 52  (13.25)
8 week point 31.39  (12.37)
14 week point 26.10  (7.89)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description upto 200 mg
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine
Affected / at Risk (%)
Total   0/48 (0.00%) 
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: Dr. Mani Pavuluri
Organization: Uillinois
Phone: 312 4130064
EMail: mpavuluri@psych.uic.edu
Layout table for additonal information
Responsible Party: Mani Pavuluri, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00176228     History of Changes
Other Study ID Numbers: 2003-04
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: June 20, 2013
Results First Posted: July 30, 2015
Last Update Posted: July 30, 2015