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Paliperidone, formulation · 1 trial · 4 indications
Venous blood samples will be collected at 8 scheduled time points after dosing and compared to fingerstick-based capillary blood samples collected at 6 scheduled time points after dosing.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Aripiprazole | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort B: Olanzapine | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort C: Paliperidone | EXPERIMENTAL | Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule. |
| Cohort D: Quetiapine | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort E: Risperidone | EXPERIMENTAL | Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule. |
| Name | Type | Description |
|---|---|---|
| Aripiprazole, oral formulation | DRUG | Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications. |
| Olanzapine, oral formulation | DRUG | Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications. |
| Paliperidone, oral formulation | DRUG | Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Paliperidone, LAI | DRUG | Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications. |
| Quetiapine, oral formulation | DRUG | Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Risperidone, oral formulation | DRUG | Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Risperidone, LAI | DRUG | Risperidone LAI injections will be administered will be administered per the locally approved label indications. |
Inclusion Criteria: * Must be clinically stable as per the investigator's judgment (no suicidal behavior or current significant suicidal judgment based on C-SSRS rating scale) * No hospitalization for exacerbation of psychiatric symptoms during 3 months before screening * Receiving treatment with a...
Paliperidone is an investigational small molecule being developed by Johnson & Johnson (JNJ) for psychiatric conditions including schizoaffective disorder, affective psychosis, bipolar disorder, and schizophrenia. It is currently in Phase 3 clinical development, though all 27 listed trials have been completed.
Paliperidone is developed by Johnson & Johnson, traded as JNJ on the stock exchange. The company is conducting clinical research on this small molecule for psychiatric indications such as schizophrenia and schizoaffective disorder.
Paliperidone is in Phase 3 clinical development. It remains investigational and has not been reported as FDA approved. All 27 clinical trials associated with the drug are completed, with no active trials currently listed.
Paliperidone has completed trials including NCT00791622 (QT interval study in schizophrenia and schizoaffective disorder), NCT00796640 (pharmacokinetics in schizophrenia), NCT01060228 (drug interaction with valproic acid), and NCT02634463 (immunoassay development). These trials enrolled a total of 7,564 participants.
Paliperidone is not the same as risperidone, but it is related. One completed trial (NCT02634463) collected samples from participants taking either aripiprazole, olanzapine, paliperidone, or risperidone to develop antipsychotic immunoassays, indicating they are distinct compounds studied together.