A Pharmacokinetic Study of Lithium Before and During Topiramate Dosing in Bipolar Disorder Patients
A Comparative Study of the Steady State Pharmacokinetics of Lithium Before and During Multiple Oral Daily Topiramate (RWJ-17021) Dosing in Patients With Bipolar Disorders
1 other identifier
interventional
32
0 countries
N/A
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 steady-state pharmacokinetics (absorption, distribution and excretion of the drug by the body) of lithium carbonate in patients with bipolar disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedJune 10, 2011
April 1, 2010
September 25, 2009
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the potential pharmacokinetic interaction between topiramate and lithium in patients with bipolar disorders
In each sampling period, blood (lithium and topiramate concentrations) is collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-morning dose, and urine (lithium concentration) was collected at 0-2, 2-4, 4-8, and 8-12 hours postdose
Secondary Outcomes (1)
No Secondary Outcomes
Study Arms (2)
001
EXPERIMENTAL002
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 29, 2009
Study Start
March 1, 2001
Study Completion
October 1, 2002
Last Updated
June 10, 2011
Record last verified: 2010-04