Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone
NCT ID: NCT02634463
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
81 participants
INTERVENTIONAL
2015-11-09
2016-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Antipsychotic Immunoassay Development Participants
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Duffel, , Belgium
Countries
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Other Identifiers
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CODX0001-NAP-1004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108047
Identifier Type: -
Identifier Source: org_study_id
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