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NCT00723450 · ClinicalTrials.gov registry record · Phase 3
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
A Phase 3 study of Bipolar Disorder, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT00723450: Completed Phase 3 study of Bipolar Disorder, sponsored by GlaxoSmithKline.
NCT00723450 is a Phase 3 study of Bipolar Disorder that has completed, run by GlaxoSmithKline. The registered enrollment target is 301 participants, roughly in line with the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00723450, a Phase 3 study of Bipolar Disorder, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of eff
Conditions Studied
Interventions
- DRUG lamictal
Study Locations (20)
Florida
- GSK Investigational Site - Bradenton
- GSK Investigational Site - Gainesville
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Orlando
- GSK Investigational Site - Tampa
- GSK Investigational Site - Winter Park
California
- GSK Investigational Site - San Diego
- GSK Investigational Site - Stanford
Illinois
- GSK Investigational Site - Libertyville
- GSK Investigational Site - Naperville
Kansas
- GSK Investigational Site - Overland Park
- GSK Investigational Site - Wichita
Alabama
- GSK Investigational Site - Dothan
Arizona
- GSK Investigational Site - Scottsdale
District of Columbia
- GSK Investigational Site - Washington D.C.
Georgia
- GSK Investigational Site - Smyrna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT00723450 record still lists
NCT00723450 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target.
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which lamictal is the first listed.
NCT00723450 names 20 study sites across 12 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00723450 about?
NCT00723450 is a clinical study titled "Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients". 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), ...
What is the current status of trial NCT00723450?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2008-07. Estimated completion is 2013-08.
What conditions does trial NCT00723450 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00723450?
The interventions under investigation include: lamictal (DRUG).
Who is sponsoring clinical trial NCT00723450?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00723450 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00723450's enrollment target sits among peer trials
301 25th of 162 higher than 138 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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