Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015769
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-05-04
Brief Title:
Pilot Study of Levetiracetam Keppra Registered Trademark for Bipolar Illness
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Evaluation of Levetiracetam Keppra Registered Trademark in Bipolar Illness
Status:
COMPLETED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 mgday is reached Higher doses not to exceed 4000 mgday 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
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 ie 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 mgday is reached Higher doses not to exceed 4000 mgday 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
Detailed Description:
Almost all of the approved anticonvulsant compounds with the exception of gabapentin and tiagabine have now been suggested to have acute antimanic or more long-term mood stabilizing properties Carbamazepine and valproate have gained a widely recognized role in treatment algorithms of bipolar illness and lamotrigine has shown promising antidepressant effects Levetiracetam Keppra Registered Trademark is the most recently approved anti-epileptic drug available and deserves pilot exploration in bipolar illness for a variety of reasons These include its positive side-effects profile it is a derivative of the nootropic agent piracetam which has memory-enhancing properties in animal studies it likely has a unique mechanism of action since it is not active on most of the traditional excitatory and inhibitory neurotransmitter systems it is not active on traditional anticonvulsant models such as pentylenetetrazol PTZ or maximum electroshock MES seizures but is able to stop both the development and completed phase of amygdala-kindled seizures and it is not metabolized by hepatic enzymes and thus has few adverse pharmacokinetic interactions
We propose pilot exploration of levetiracetam as an adjunctive agent in patients with bipolar illness who are inadequately responsive to routine psychopharmacological agents for bipolar illness At the NIMH we will study a maximum of 10 acutely depressed 10 manic and 10 cycling patients enrolled in Protocol 97-M-0039 We would start at Levetiracetam doses of 500 mgday and not to exceed 4000 mgday Response will be based primarily on the percentage of patients showing much or very much improvement on the GCI-BP score in each of the three groups as augmented by the percentage decrement on cross-sectional scales such as the Inventory of Depressive Symptomatology IDS and Young Mania Rating Scale YMRS in conjunction with prospective ratings on the NIMH-LCMp Should preliminary evidence of efficacy be observed in this open add-on clinical trial more systematic controlled studies will then be designed for confirmation of promising target areas of efficacy
We propose pilot exploration of levetiracetam as an adjunctive agent in patients with bipolar illness who are inadequately responsive to routine psychopharmacological agents for bipolar illness At the NIMH we will study a maximum of 10 acutely depressed 10 manic and 10 cycling patients enrolled in Protocol 97-M-0039 We would start at Levetiracetam doses of 500 mgday and not to exceed 4000 mgday Response will be based primarily on the percentage of patients showing much or very much improvement on the GCI-BP score in each of the three groups as augmented by the percentage decrement on cross-sectional scales such as the Inventory of Depressive Symptomatology IDS and Young Mania Rating Scale YMRS in conjunction with prospective ratings on the NIMH-LCMp Should preliminary evidence of efficacy be observed in this open add-on clinical trial more systematic controlled studies will then be designed for confirmation of promising target areas of efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-M-0168 | None | None | None |