Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
paliperidone; Carbamazepine · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| paliperidone ER; Carbamazepine | DRUG | - |
Inclusion Criteria: * Diagnosis of schizophrenia of any subtype (295.10 * 295.20 * 295.30 * 295.60 * 295.90) or bipolar I disorder (296.0x, 296.4x, 296.5x, 296.6x or 296.7), according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * Clinically stable with no p...
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Paliperidone is an antipsychotic medicine studied for the treatment of schizophrenia. It has also been evaluated in patients with bipolar I disorder. The clinical program described here focuses on schizophrenia as the primary psychiatric indication.
Paliperidone is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical study of paliperidone extended release in patients with schizophrenia or bipolar I disorder.
Paliperidone is in Phase 1 clinical development for schizophrenia. The single listed study, NCT00892125, was a Phase 1 pharmacokinetic trial that has been completed. Paliperidone is investigational in this program and is not described as approved for this use.
Paliperidone has been studied in trial NCT00892125, titled a study of the effect of carbamazepine on the pharmacokinetics of paliperidone extended release in patients with schizophrenia or bipolar I disorder. It was a completed Phase 1 trial that enrolled 64 patients aged 18 years and older.
Yes, paliperidone ER refers to the extended release formulation of paliperidone. The trial NCT00892125 specifically examined paliperidone extended release, so the two names describe the same active drug given in different formulations.
The paliperidone trial NCT00892125 was an uncontrolled Phase 1 study, not randomized and not double blind, that enrolled 64 patients with schizophrenia or bipolar disorder. It assessed how carbamazepine affects the pharmacokinetics of paliperidone extended release.