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Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone

2015-12-21 06:04:46 | BioPortfolio

Summary

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.

Description

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Antipsychotic

Intervention

Aripiprazole, Olanzapine, Paliperidone, Risperidone

Location

Duffel
Belgium

Status

Recruiting

Source

Janssen Research & Development, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-12-21T06:04:46-0500

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Medical and Biotech [MESH] Definitions

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