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NCT00181844 · ClinicalTrials.gov registry record · Phase 4
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT00181844: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00181844 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00181844, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.
Primary Outcome
Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Interventions
- DRUG lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00181844 record still lists
NCT00181844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which lamotrigine is the first listed.
NCT00181844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00181844 about?
NCT00181844 is a clinical study titled "Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder". The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for b...
What is the current status of trial NCT00181844?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2005-01. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00181844?
The interventions under investigation include: lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00181844?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00181844's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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