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NCT00621842 · ClinicalTrials.gov registry record · Phase 3
Lamotrigine for Symptoms of Geriatric Bipolar Depression
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
NCT00621842: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00621842 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 57 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621842, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
Primary Outcome
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Interventions
- DRUG Lamotrigine regular tablet formulation
- DRUG Lamotrigine novel formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00621842 record still lists
NCT00621842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine regular tablet formulation is the first listed.
NCT00621842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00621842 about?
NCT00621842 is a clinical study titled "Lamotrigine for Symptoms of Geriatric Bipolar Depression". This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders ...
What is the current status of trial NCT00621842?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2008-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00621842?
The interventions under investigation include: Lamotrigine regular tablet formulation (DRUG), Lamotrigine novel formulation (DRUG).
Who is sponsoring clinical trial NCT00621842?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00621842's enrollment target sits among peer trials
57 1827th of 2000 higher than 174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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