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NCT00015769 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00015769 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 30 participants.
The verdict
NCT00015769, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate, are widely recognized as substitute medications for lithium or are used as an adjunct to it, and other anticonvulsants have also shown promise in improving bipolar symptoms. Patients with bipolar illness whose manic, depressed or unstable moods are not adequately controlled by their current treatment and who have not responded previously to two standard treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this study. Participants will take levetiracetam starting at 500 mg daily. If this dose is well tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may be tried in patients who do not respond fully to the lower doses. Patients and observers will use standard ratings to evaluate the patients' response to therapy during the 8-week study. If, after 8 weeks, the results appear promising, patients may continue treatment for an additional 6 months to evaluate longer-term effects.
Interventions
- DRUG levetiracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-04 |
| Est. Completion | 2003-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00015769
The ClinicalTrials.gov registry entry for NCT00015769 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 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 levetiracetam is the first listed.
NCT00015769 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00015769 about?
NCT00015769 is a clinical study titled "Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness". This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate,...
What is the current status of trial NCT00015769?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2001-04. Estimated completion is 2003-04.
What interventions are being tested in trial NCT00015769?
The interventions under investigation include: levetiracetam (DRUG).
Who is sponsoring clinical trial NCT00015769?
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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