Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176228
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2005-09-13
Brief Title:
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Open Trial of Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are two purposes for this project Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder Phases mixed manic hypomanic or depressed episodes in 8-17 year old children These children and adolescents must be treatment resistant who failed on two adequate trials of mood stabilizing medications to qualify for this study Study 2 is aimed at examining brain activity andor dysfunction before lamotrigine treatment and to look for any alteration after lamotrigine treatment Brain systems associated with attention and emotional processing will targeted
Detailed Description:
Procedure Study 1 This study is planned to be conducted over 18 months with an average recruitment of 2 subjects per month Each subject is involved in the study for 18 to 26 weeks While the study medication is dosed over 8 weeks and treated with full dose over 6 weeks withdrawal of medications that are on board prior to the study drug administration and drug free period post washout required additional time line that is up to 12 weeks over and above the 14 weeks of administering the study drug Conversely the range of time is necessary to account for factors such as the childs age sex weight reactions to the medications and side effects Based on these factors the time it takes to titrate the medication dose to the optimal amount will vary Maintaining this flexibility in the protocol is part of good clinical practice where medication is involved Only children whose medication is not currently improving their symptoms will be recruited Therefore no children who have been stabilized on a drug will be taken off of it The initial 2 week screening period includes a diagnostic interview and collection of demographic information Previous medication will be tapered slowly over 2-12-week period and is based on tolerability and need to keep subjects in drug free state prior to start of study medication It is an open trial where subjects are aware of the type of medication and the strength For example one pill25 mg strength of the pill Research assessment of mood symptoms and side effects will be carried out 5 times over the course of the active trial period Blood will be collected 3 times once the subject is washed-out baseline once optimal medication dose has been reached and finally at the end of the 6-week period on full dose
The dose of lamotrigine will be 125 mg per day beginning the first day It is increased in 125 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg Increasing the medication to final dose will take 8 weeks and the response on full and tolerable dose is further monitored for response over 6 weeks Therefore this is a 18-26 week trial 2 to 12 weeksscreening and wash out 8 weeksdosing 6 weeksacute trial period on full dose
Study 2 involves adolescent subjects 10years of age recruited from the Study 1 sample This part of the study is a fMRI treatment study to examine how the brain functions before and after receiving lamotrigine medication for bipolar disorder The goal of study 2 is to understand how and where lamotrigine works in the brain In order to do this we will view brain images in a fMRI scanner pre- and post-treatment This will be done once before subjects begin taking lamotrigine subjects who require a wash-out period described in study 1 this will occur after the wash-out The second scan will take place after the medication trial after the 6-week active treatment period While in the scanner subjects will complete tasks related to thinking and emotion Subjects will be shown pictures of faces with varying expressions including happy neutral and angry and will be asked to identify the emotions of the faces remember and identify previously seen faces and determine the age group of various faces ie above or below 30 years Subjects will also complete tasks that involve processing words that express different emotions eg happy angry and respond to different go and no-go images that flash on a screen Brain activity will be recorded during these tasks Each task will take around 5 minutes Before the actual fMRI scan subjects practice lying in a simulator a machine that looks and sounds like a scanner
The dose of lamotrigine will be 125 mg per day beginning the first day It is increased in 125 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg Increasing the medication to final dose will take 8 weeks and the response on full and tolerable dose is further monitored for response over 6 weeks Therefore this is a 18-26 week trial 2 to 12 weeksscreening and wash out 8 weeksdosing 6 weeksacute trial period on full dose
Study 2 involves adolescent subjects 10years of age recruited from the Study 1 sample This part of the study is a fMRI treatment study to examine how the brain functions before and after receiving lamotrigine medication for bipolar disorder The goal of study 2 is to understand how and where lamotrigine works in the brain In order to do this we will view brain images in a fMRI scanner pre- and post-treatment This will be done once before subjects begin taking lamotrigine subjects who require a wash-out period described in study 1 this will occur after the wash-out The second scan will take place after the medication trial after the 6-week active treatment period While in the scanner subjects will complete tasks related to thinking and emotion Subjects will be shown pictures of faces with varying expressions including happy neutral and angry and will be asked to identify the emotions of the faces remember and identify previously seen faces and determine the age group of various faces ie above or below 30 years Subjects will also complete tasks that involve processing words that express different emotions eg happy angry and respond to different go and no-go images that flash on a screen Brain activity will be recorded during these tasks Each task will take around 5 minutes Before the actual fMRI scan subjects practice lying in a simulator a machine that looks and sounds like a scanner
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None