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

NCT02634463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Immunoassay
  • Antipsychotic

Interventions

DRUG

Aripiprazole

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.

OTHER

Olanzapine

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.

DRUG

Paliperidone

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.

DRUG

Risperidone

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2016-11-09
Completion
2016-11-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634463 on ClinicalTrials.gov