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Completed Phase 3 Interventional Results available

Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients

ClinicalTrials.gov ID: NCT00723450

Public ClinicalTrials.gov record NCT00723450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 7:56 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00723450
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
301 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2008 (Type not available)
Primary completion
Aug 2013 (Actual)
Completion
Aug 2013 (Actual)
Last update posted
Jan 9, 2017

2008 – 2013

United States locations

U.S. sites
46
U.S. states
26
U.S. cities
42
Facility City State ZIP Site status
GSK Investigational Site Dothan Alabama 36305 —
GSK Investigational Site Scottsdale Arizona 85252 —
GSK Investigational Site San Diego California 92108 —
GSK Investigational Site Stanford California 94304 —
GSK Investigational Site Washington D.C. District of Columbia 20010 —
GSK Investigational Site Bradenton Florida 34201 —
GSK Investigational Site Gainesville Florida 32607 —
GSK Investigational Site Jacksonville Florida 32216 —
GSK Investigational Site Orlando Florida 32839 —
GSK Investigational Site Tampa Florida 33613 —
GSK Investigational Site Winter Park Florida 32789 —
GSK Investigational Site Smyrna Georgia 30080 —
GSK Investigational Site Libertyville Illinois 60048 —
GSK Investigational Site Naperville Illinois 60563 —
GSK Investigational Site Indianapolis Indiana 46202 —
GSK Investigational Site Overland Park Kansas 66211 —
GSK Investigational Site Wichita Kansas 67206 —
GSK Investigational Site Shreveport Louisiana 71103 —
GSK Investigational Site Baltimore Maryland 21208 —
GSK Investigational Site Boston Massachusetts 02114 —
GSK Investigational Site Boston Massachusetts 02115 —
GSK Investigational Site Springfield Massachusetts 01199 —
GSK Investigational Site Worcester Massachusetts 01655 —
GSK Investigational Site Rochester Minnesota 55905 —
GSK Investigational Site Saint Charles Missouri 63304 —
GSK Investigational Site Lincoln Nebraska 68526 —
GSK Investigational Site Piscataway New Jersey 08854 —
GSK Investigational Site Albuquerque New Mexico 87109 —
GSK Investigational Site Mount Kisco New York 10549 —
GSK Investigational Site Stony Brook New York 11794-8790 —
GSK Investigational Site Chapel Hill North Carolina 27517 —
GSK Investigational Site Fargo North Dakota 58104 —
GSK Investigational Site Cincinnati Ohio 45219 —
GSK Investigational Site Cincinnati Ohio 45229 —
GSK Investigational Site Cleveland Ohio 44106 —
GSK Investigational Site Columbus Ohio 43210 —
GSK Investigational Site Toledo Ohio 43609 —
GSK Investigational Site Philadelphia Pennsylvania 19104 —
GSK Investigational Site Dallas Texas 75235 —
GSK Investigational Site Houston Texas 77007 —
GSK Investigational Site Houston Texas 77008 —
GSK Investigational Site Houston Texas 77030 —
GSK Investigational Site Salt Lake City Utah 84105 —
GSK Investigational Site Roanoke Virginia 24013 —
GSK Investigational Site Kirkland Washington 98033 —
GSK Investigational Site Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00723450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 9, 2017 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00723450 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →