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Psychotic Disorders | Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants

Psychotic Disorders research study

What is the primary objective of this study?

The purpose of this study is to gather information about the steady-state plasma concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at various dose levels and at different time points after dosing. In addition, comparison of capillary drug concentrations vs. venous drug concentrations will be performed for aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant metabolites.

Who is eligible to participate?

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 aripiprazole, olanzapine, paliperidone, quetiapine or risperidone, or their combination before the study - Must have body mass index between 17 and 40 kg/m2 (inclusive), and body weight not less than 47 kg - Except for the indication for which the antipsychotic treatment is given, generally healthy with no clinically significant or unstable medical problems - Must be able to give informed consent Exclusion Criteria: - Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as determined by the investigator - Administering of strong inhibitors or inducers of CYP3A4, CYP2D6 enzymes, like fluoxetine - History of or current clinically significant (particularly unstable) medical illness other than the indication - Donated blood or blood products or had substantial loss of blood (more than 450 mL) within 3 months before Day -1 - Lack of 6 suitable puncture sites for capillary blood draws

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Psychotic Disorders

Schizophrenia

Bipolar Disorder

Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Aripiprazole, oral formulationAripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.

Drug:Olanzapine, oral formulationOlanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.

Drug:Paliperidone, oral formulationPaliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

Drug:Paliperidone, LAIPaliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.

Drug:Quetiapine, oral formulationQuetiapine 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.

Drug:Risperidone, oral formulationRisperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

Drug:Risperidone, LAIRisperidone LAI injections will be administered will be administered per the locally approved label indications.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cohort A: AripiprazoleAdministration of oral formulation will continue at a participant's usual dose and dosing schedule.

Cohort B: OlanzapineAdministration of oral formulation will continue at a participant's usual dose and dosing schedule.

Cohort C: PaliperidoneAdministration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule.

Cohort D: QuetiapineAdministration of oral formulation will continue at a participant's usual dose and dosing schedule.

Cohort E: RisperidoneAdministration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule.

Study Status

Completed

Start Date: February 2014

Completed Date: December 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Aripiprazole concentration in venous and capillary plasma

Secondary Outcome: Number of participants with an adverse event as a measure of safety

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02087579

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