CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
lamotriginedrug
Likely dose
For children <12 years: starting dose 0.35 mg/kg/day divided in 2 doses, increased weekly to maintenance 5-15 mg/kg/day (max 400 mg/day). For children ≥12 years: starting dose 25 mg/day, increased to maintenance 100-200 mg/day (max 400 mg/day)AI-extracted
Key inclusion· 6
  • ✓Age 6-17 years
  • ✓DSM-IV diagnosis of bipolar I, bipolar II disorder, or bipolar spectrum disorder with current manic, hypomanic, or mixed symptoms (with or without psychotic features)
  • ✓Y-MRS total score ≥20 at baseline
  • ✓Able to swallow pills and participate in mandatory blood draws
Key exclusion· 10
  • ✕Known severe allergy or multiple adverse drug reactions to lamotrigine
  • ✕History of bone marrow depression
  • ✕History of serious rashes
  • ✕Substance dependence (except nicotine or caffeine) within past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00181844
NCT00181844Phase 4Completed
CompareCT.gov

A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders

Massachusetts General Hospital·interventional·Posted Sep 16, 2005·Updated Apr 6, 2012

In Brief

A Phase 4 clinical trial evaluating lamotrigine for Bipolar Disorder and Mania. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Mania
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJan 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

lamotriginedrug

Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children \<12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.