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

NCT00986336 | Completed Phase 1

• 1 other identifier: CR002857
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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 administered in combination in patients with a history of either bipolar spectrum or schizoaffective (bipolar type) disorders as defined by DSM-IV criteria.

Conditions

Bipolar Disorder

Keywords

topiramate; risperidone, bipolar disorder

Outcome Measures

Primary Outcomes (1)

• To evaluate the potential pharmacokinetic interaction between topiramate and risperidone in patients with bipolar disorder or schizoaffective disorders.

  At each sampling visit during Periods I, II and III, blood and urine collected pre-morning dose and over a period of 12 hours post-dose.

Secondary Outcomes (1)

• Assess the safety of multiple doses of topiramate in combination with varying doses of risperidone

  At each sampling visit during Periods I, II and III

Study Arms (4)

001

EXPERIMENTAL

Drug: topiramate

002

EXPERIMENTAL

Drug: topiramate

003

EXPERIMENTAL

Drug: topiramate

004

EXPERIMENTAL

Drug: risperidone

Interventions

topiramate DRUG

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

002

risperidone DRUG

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

004

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Links

• A comparative study of the steady-state pharmacokinetics of risperidone and topiramate on monotherapy and during combination therapy in subjects with bipolar or schizoaffective disorders

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Topiramate; Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

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

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

  STUDY DIRECTOR

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: February 1, 2001
• Study Completion: November 1, 2002
• Last Updated: June 10, 2011

Record last verified: 2010-04