Status:
COMPLETED
A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the potential pharmacokinetic (absorption, distribution and excretion of the drug by the body) interaction between, and the safety of, topiramate and risperidone...
Detailed Description
This was an open-label (both the investigator and the patient knew the identity of the study drug), nonrandomized pharmacokinetic (PK) study evaluating the interaction of topiramate and risperidone in...
Eligibility Criteria
Inclusion
- Patients meeting DSM-IV criteria for either Bipolar I Disorder, Bipolar II Disorder, Cyclothymic Disorder, Bipolar Disorder NOS, or Schizoaffective Disorder (bipolar type)
- Patients not in the midst of an acute manic, major depressive, or schizoaffective episode and had not experienced an acute episode within the month prior to screening
- Women were to be 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 using prescription medication, including psychotropic medications, within 14 days prior to the first day of Period I with the exception of hormonal contraceptives (women), risperidone, or other medications approved by the sponsor
- Patients on depot medications (including but not limited to haloperidol decanoate)
- Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis in the month prior to beginning TPM titration.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00986336
Start Date
February 1 2001
End Date
November 1 2002
Last Update
June 10 2011
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