The purpose of this study is to collect whole blood and plasma venous and capillary samples from participants taking aripiprazole, olanzapine, paliperidone, or risperidone for the development of antipsychotic immunoassays.
This is a Phase 0, multicenter (when more than one hospital work on a medical research study) study including participants taking aripiprazole, olanzapine, paliperidone or risperidone. Participants will provide blood samples to be used in development of antipsychotic immunoassays. At different times, assay development will require venous, capillary, or both types of blood samples. Overall, at a single study visit, a minimum of approximately 0.1 milliliter (mL) to a maximum of approximately 15 mL of blood will be collected from all sources. Across all study visits, a maximum of 450 mL of blood will be collected from a participant. The frequency of collections (study visits) will depend on the needs of assay development. A particular participant may participate for only 1 sample collection or multiple sample collections (study visits). This study will continue for an indefinite period of time. The participant's direct involvement in the study will be continued until the study is ended, the participant has given 450 mL of blood, or the participant withdraws consent or is excluded from participation for medical and/or inclusion/exclusion criteria reasons. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
81
No study agent will be administered as a part of this study. Participants must be on Aripiprazole 5 milligram (mg) (minimum dose) to 30 mg (maximum dose), orally, daily or long-acting injectable versions (300-400 mg once every 4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for development of antipsychotic immunoassays.
No study agent will be administered as a part of this study. Participants must be on Olanzapine 5 mg (minimum dose) to 30 mg (maximum dose), orally, daily or long-acting injectable versions (150-405 mg once every 2-4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.
Unnamed facility
Duffel, Belgium
Immunoassay Antipsychotic In Blood
Whole blood and plasma venous and capillary samples will be collected from participants taking aripiprazole, olanzapine, paliperidone, or risperidone to determine the concentration, which will be used in the development of antipsychotic immunoassays.
Time frame: Up to 1 year
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No study agent will be administered as a part of this study. Participants must be on Paliperidone 3 mg (minimum dose) to 12 mg (maximum dose), orally, daily or long-acting injectable versions (25-150 mg equivalent \[eq.\] once every 4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.
No study agent will be administered as a part of this study. Participants must be on Risperidone 1 mg (minimum dose) to 8 mg (maximum dose), orally, daily or long-acting injectable versions (12.5-50 mg once every 2 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.