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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 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.

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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).

Conditions Studied

Bipolar Disorder

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

FieldValue
Enrollment Target 301 participants
Start Date 2008-07
Est. Completion 2013-08
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00723450

The ClinicalTrials.gov registry entry for NCT00723450 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.