ImmunoassayPhase 1NCT02634463
Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone
A Phase 1 study testing Aripiprazole, Olanzapine and Paliperidone in people with Immunoassay and Antipsychotic, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoassay, Antipsychotic
- What is being tested?
- Aripiprazole, Olanzapine and Paliperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Nov 2015to 9 Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Immunoassay, Antipsychotic
- Being tested
- Aripiprazole, Olanzapine, Paliperidone, Risperidone
- Keywords
- Immunoassay, Antipsychotic, Aripiprazole, Olanzapine, Paliperidone, Risperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
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.
OlanzapineOther
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.
PaliperidoneDrug
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.
RisperidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aripiprazole; Other: Olanzapine; Drug: Paliperidone; Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start9 Nov 2015
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunoassayStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634463
- Sponsor's protocol ID
- CR108047
- Other IDs
- CODX0001-NAP-1004
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2015
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone
- ClinicalTrials.gov ID
- NCT02634463
- Acronym / sponsor ID
- CR108047
- Conditions
- Immunoassay, Antipsychotic
- Keywords
- Immunoassay, Antipsychotic, Aripiprazole, Olanzapine, Paliperidone, Risperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic Immunoassay Development Participants | Other | Drug: Aripiprazole, Other: Olanzapine, Drug: Paliperidone, Drug: RisperidoneNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleNo 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. | Drug | Antipsychotic Immunoassay Development Participants |
| OlanzapineNo 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. | Other | Antipsychotic Immunoassay Development Participants |
| PaliperidoneNo 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 | Antipsychotic Immunoassay Development Participants |
| RisperidoneNo 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. | Drug | Antipsychotic Immunoassay Development Participants |
Primary outcome
Immunoassay Antipsychotic In Blood
Time frame: Up to 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aripiprazole, Olanzapine and Paliperidone in people with Immunoassay and Antipsychotic, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoassay Antipsychotic In Blood (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.