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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. 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.
Interventions
- DRUG lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00181844
The ClinicalTrials.gov registry entry for NCT00181844 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lamotrigine is the first listed.
NCT00181844 reports 0 study locations.
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.
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