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A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders

NCT00986336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-06-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

topiramate

1-25 mg plus 1-100 mg tablet twice daily for 2 weeks (250 mg/day)

DRUG

topiramate

2-100 mg tablets twice daily for 2 weeks (400 mg/day)

DRUG

risperidone

Twice daily, individualized dosing to stabilization at 1-6 mg/day.

DRUG

topiramate

2-25 mg tablets twice daily for 2 weeks (100 mg/day)

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Completion
2002-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986336 on ClinicalTrials.gov