CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
lamictaldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00723450
NCT00723450Phase 3Completed
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The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age

GlaxoSmithKline·interventional·Posted Jul 28, 2008·Updated Jan 9, 2017

In Brief

A Phase 3 clinical trial evaluating lamictal for Bipolar Disorder. Completed, enrolled 301 participants across 46 sites.

Detailed Summary

The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2008
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.9 years ago

Interventions

lamictaldrug

Flexible Dosing