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NCT00176228 · ClinicalTrials.gov registry record · Phase 2
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00176228: Completed Phase 2 study, sponsored by University of Illinois at Chicago.
NCT00176228 is a Phase 2 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00176228, a Phase 2 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be treatment resistant (who failed on two adequate trials of mood stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain activity and/or dysfunction before lamotrigine treatment, and to look for any alteration after lamotrigine treatment. Brain systems associated with attention and emotional processing will targeted.
Primary Outcome
This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior
Interventions
- DRUG Lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2004-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00176228 record still lists
NCT00176228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Lamotrigine is the first listed.
NCT00176228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00176228 about?
NCT00176228 is a clinical study titled "Lamotrigine Monotherapy in Pediatric Bipolar Disorder". There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be ...
What is the current status of trial NCT00176228?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2004-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00176228?
The interventions under investigation include: Lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00176228?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00176228's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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