drugset / Trial / NCT00986336
A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders
Non-randomizedSingle-groupOpen-labelTreatment
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 administered in combination in patients with a history of either bipolar spectrum or schizoaffective (bipolar type) disorders as defined by DSM-IV criteria.
Timeline
- Start
- 2001-02
- Primary completion
- —
- Completion
- 2002-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 1 mg | — |
| Subject | Risperidone | Other / unclassified | 6 mg | — |
| Subject | Topiramate | Small molecule | 100 mg | — |
| Subject | Topiramate | Small molecule | 250 mg | — |
| Subject | Topiramate | Small molecule | 400 mg | — |