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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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