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

NCT02634463 | Completed Phase 1

• 2 other identifiers: CR108047CODX0001-NAP-1004
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immunoassay; Antipsychotic; Aripiprazole; Olanzapine; Paliperidone; Risperidone

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Study Arms (1)

Antipsychotic Immunoassay Development Participants

OTHER

No study agent will be administered as a part of this study. Participants must be on Aripiprazole or Olanzapine, or Paliperidone or Risperidone, orally, daily or long-acting injectable versions, 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 use in the development of antipsychotic immunoassays. Participants may also be on long acting injectable versions of the medication.

Drug: Aripiprazole; Other: Olanzapine; Drug: Paliperidone; Drug: Risperidone

Interventions

Aripiprazole DRUG

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.

Antipsychotic Immunoassay Development Participants

Olanzapine OTHER

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.

Antipsychotic Immunoassay Development Participants

Paliperidone DRUG

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.

Antipsychotic Immunoassay Development Participants

Risperidone DRUG

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.

Antipsychotic Immunoassay Development Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women who are at least 18 years of age
• Must be taking one or more of the following antipsychotic medications: aripiprazole, olanzapine, paliperidone, and/or risperidone as part of the treatment for a psychiatric illness
• Must be psychiatrically stable as determined by their psychiatrist or similar clinician. The participant must not have had suicidal behavior or clinically significant suicidal ideation during the week prior to Screening, according to the investigator's judgment
• Generally healthy and has no clinically significant or unstable medical problems as determined by the investigator, except for the indication for which the antipsychotic treatment is being prescribed. This determination must be recorded in the participant's source documents and initialed by the investigator
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent cannot be given by a guardian or other person

You may not qualify if:

• Participants who regularly miss more than one dose of antipsychotic medication in a typical week
• During Screening or during the conduct of the study, the participant has an active substance use disorder of moderate or severe intensity except for tobacco (Diagnostic and Statistical Manual of Mental Disorders \[DSM-5\] definition) or acute intoxication at any study visit as determined by the investigator
• Donated blood or had blood loss of greater than (\>) 450 milliliter (mL) in the past 3 months. Participants may not donate blood during participation in the study
• Any participant who has had a surgical and/ or biopsy procedure within the last 6 weeks. For enrolled participants, additional study-related blood draws will need to be delayed for at least 6 weeks after such a procedure or significant blood loss
• Any participant who has had a negative reaction to a blood draw (such as fainting) in the past

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Duffel, Belgium

Location

MeSH Terms

Interventions

Aripiprazole; Olanzapine; Paliperidone Palmitate; Risperidone

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Isoxazoles; Azoles; Pyrimidines; Pyrimidinones

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: December 18, 2015
• Study Start: November 9, 2015
• Primary Completion: November 9, 2016
• Study Completion: November 9, 2016
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

BE (1)