The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.

This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.

The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets).

This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.

Inclusion Criteria for Cohort 1:

• In good general health or medically stable.
• Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
• The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant.

Inclusion Criteria for Cohort 2:

• In good general health or medically stable.
• Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole.
• Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
• Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant

Exclusion Criteria for Cohort 1 and 2:

• Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing.
• Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing.
• Difficulty with or inability to swallow tablets.
• Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis).
• The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin).
• Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex.
• Positive urine pregnancy test at screening visit (dipstick).
• Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com

Enrolled analysis set included all participants who signed an informed consent form (ICF) and entered the study (and only participants who met all the inclusion criteria and none of the exclusion criteria).

From Day 1 up to follow-up (up to Day 10)

Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.