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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00892125 |
The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER and to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Bipolar Disorder |
Drug: paliperidone ER |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Evaluation of the Effect of Carbamazepine on the Steady-State Pharmacokinetics of Paliperidone Extended Release in Clinically Stable Subjects With Schizophrenia or Bipolar I Disorder |
Estimated Enrollment: | 60 |
Study Start Date: | September 2006 |
Study Completion Date: | March 2007 |
The current study is designed as an open-label, multiple-center, multiple-dose, 2 treatment, 2 period sequential drug interaction study. It consists of 3 phases: a screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2), during which patients will receive multiple oral doses of 6-mg paliperidone ER alone or in combination with multiple oral doses of carbamazepine, and end of study evaluations upon completion of all the study procedures in Period 2 or at early withdrawal. There is no washout period between treatment periods. Given the potential concomitant use of carbamazepine with antipsychotics, such as paliperidone ER, in the treatment of schizophrenia or bipolar I disorder, this study is designed to investigate the effect of carbamazepine on the steady-state pharmacokinetics of paliperidone ER. Safety and tolerability will be monitored throughout the study..
Period 1: 6 mg paliperidone ER once daily from Day 1 through Day 7, route oral; Period 2: 6 mg paliperidone ER once daily and carbamazepine 200 mg twice daily from Day 8 through Day 28, route oral.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In addition, an increase or decrease in the dose of a mood stabilizer on the basis of therapeutic drug monitoring or the substitution of a specific mood stabilizer, antipsychotic, or anti-manic drug for another because of poor tolerability will be allowed within 3 months before screening
Exclusion Criteria:
Intermittent substance abuse in the months before screening will not be exclusionary, depending upon the clinical judgment of the investigator, with the exception of barbiturates
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR011440 |
Study First Received: | November 20, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00892125 History of Changes |
Health Authority: | United States: Food and Drug Administration |
antipshychotic drugs Paliperidone ER Bipolar I disorder |
mood disorders enzyme inducer Schizophrenia |
Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Risperidone Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Antimanic Agents Schizophrenia Affective Disorders, Psychotic |
Carbamazepine Mental Disorders Analgesics, Non-Narcotic Mood Disorders Psychotic Disorders Analgesics Peripheral Nervous System Agents Anticonvulsants Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Disease Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Antimanic Agents Pharmacologic Actions Schizophrenia Affective Disorders, Psychotic |
Pathologic Processes Carbamazepine Mental Disorders Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Mood Disorders Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants Schizophrenia and Disorders with Psychotic Features |