Schizophrenia Clinical Trial
Official title:
An Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Paliperidone Extended-Release on the Steady-State Pharmacokinetics of Valproic Acid in Clinically Stable Subjects With Schizophrenia, Bipolar I Disorder or Schizoaffective Disorder
The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder.
Status | Completed |
Enrollment | 9 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Have a diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) - Is clinically stable with no psychiatric hospitalization or change in existing mood stabilizers, antipsychotic, or anti-manic drugs for 1 month before screening - Taking valproate (valproic acid, sodium valproate, or divalproex sodium) for a minimum of 4 weeks before screening with a stable therapeutic dose for a minimum of 2 weeks and have confirmed therapeutic blood concentrations at screening - If a woman, be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study - If a man, agrees to use an adequate contraception method as deemed appropriate by the Investigator and to not donate sperm using the study and for 3 months after receiving the last dose of study drug Exclusion Criteria: - Meet DSM-IV criteria for rapid cycling if primary diagnosis is bipolar I disorder - DSM-IV diagnosis of alcohol or substance abuse with the exception of nicotine or caffeine dependence, within 12 months before screening - Current suicidal ideation or violent tendencies at the time of screening - History of neuroleptic malignant syndrome, any malignancy (with exception of basal cell carcinoma) within the past 5 years, any severe pre-existing gastrointestinal narrowing, or any history (or presence) of any cardiovascular, respiratory, neurologic, renal, hepatic, gastrointestinal, endocrine, hematologic, or immunologic disease - moderate or severe tardive dyskinesia at the time of screening - known allergy or intolerance of study drugs (ie, paliperidone, the parent compound risperidone, valproic acid, sodium valproate, or divalproex sodium) or any of the excipients of the formulations (eg, lactose) |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the potential effect of multiple doses of paliperidone ER tablets on the steady state pharmacokinetics of VPA. | Blood samples collected at specified times on Days 4 through 13. | No | |
Secondary | To evaluate safety and tolerability of paliperidone ER coadministered with divalproex sodium ER | From time of screening (Day -21 up to Day -2) through the posttreatment follow-up visit 1 week after the end-of-study visit (Day 13 or time of early withdrawal from study) | No |
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