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NCT00305578 · ClinicalTrials.gov registry record · Phase 4
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT00305578: Completed Phase 4 study, sponsored by Indiana University.
NCT00305578 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305578, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. Subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.
Primary Outcome
Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.
Interventions
- DRUG Placebo
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2005-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT00305578 record still lists
NCT00305578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00305578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305578 about?
NCT00305578 is a clinical study titled "Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression". The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatm...
What is the current status of trial NCT00305578?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2005-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00305578?
The interventions under investigation include: Placebo (DRUG), Memantine (DRUG).
Who is sponsoring clinical trial NCT00305578?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00305578's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 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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