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NCT00034229 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00034229: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00034229 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00034229, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate for treating depression in patients with bipolar disorder that has not responded to standard treatments. Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the availability of a wide range of antidepressant drugs, a proportion of patients fail to respond to first-line antidepressant treatment despite adequate dosage, duration, and compliance. Studies suggest that the glutamatergic system may play a role in the pathophysiology and treatment of depression. Felbamate and other agents which reduce glutamatergic neurotransmission may represent a novel class of antidepressants. Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At study entry, participants will have a 7-day washout period in which they will be tapered off all psychiatric medications, with the possible exception of lithium, and will be given a placebo (an inactive pill). After the washout period, participants will be randomly assigned to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms worsen by more than 30% or those for whom study continuation is considered potentially harmful will be taken off the study and offered open-label treatment. Participants who received felbamate and responded well to treatment will have the option of continuing treatment.
Interventions
- DRUG Felbamate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2002-04 |
| Est. Completion | 2006-03 |
| Phase | Phase 2 |
What the finished NCT00034229 record still lists
NCT00034229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Felbamate is the first listed.
NCT00034229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00034229 about?
NCT00034229 is a clinical study titled "Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression". The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate for treating depression in patients with bipolar disorder that has not responded to standard treatments. Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the availability of...
What is the current status of trial NCT00034229?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2002-04. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00034229?
The interventions under investigation include: Felbamate (DRUG).
Who is sponsoring clinical trial NCT00034229?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00034229's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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