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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 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 52 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00034229
The ClinicalTrials.gov registry entry for NCT00034229 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Felbamate is the first listed.
NCT00034229 reports 0 study locations.
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.
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