Status:
COMPLETED
A Pharmacokinetic Study of Lithium Before and During Topiramate Dosing in Bipolar Disorder Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the initial (after 1-week of maintenance dosing) and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600 mg/day, on the st...
Detailed Description
This was an open-label (both the investigator and the patient knew the identity of the study drug), sequential treatment, multicenter study evaluating the interaction of topiramate and lithium in pati...
Eligibility Criteria
Inclusion
- Patients meeting DSM-IV criteria for either Bipolar I, Bipolar II, Cyclothymic Disorder, or Bipolar Disorder NOS
- Patients on monotherapy treatment with lithium carbonate at steady state level for a minimum of two weeks prior to study treatment assignment
- Women are postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline
Exclusion
- Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma
- Patients on depot medications, including but not limited to haloperidol, decanoate and Depo-Provera
- Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis (kidney stone formation) in the month prior to beginning topiramate titration
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00986128
Start Date
March 1 2001
End Date
October 1 2002
Last Update
June 10 2011
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