A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

This was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which was oral aripiprazole or any other product). Eligible participants entered a screening period of up to 13 days. For participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.

After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at Day 360. During this second, optional interventional period, participants may have started and stopped Abilify MyCite as clinically indicated.

A parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.

• Abilify MyCite - Digital Medicine System (Combination product): The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).
• Aripiprazole or other oral antipsychotics (Drug): For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.

Primary outcomes

• Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 [Baseline through Day 180]: This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.

Secondary outcomes

• Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 [Baseline through Day 180]: This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.

Sex: All, ages: 18 Years to 63 Years

Inclusion Criteria:

* Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or Medicare health plan with medical and pharmacy benefits.
* Participants must have a smartphone with data plan.
* Participants currently prescribed aripiprazole, or appropriate for aripiprazole treatment.
* Participants must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

* Any participant who participated in another clinical trial within 30 days of enrollment into the current study.
* Females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study.
* Participants who are currently being treated with a long-acting injectable antipsychotic.

Participant flow

Outcome results

• Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 (Primary)
• Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 (Secondary)

Adverse events

Time frame: Baseline (Day 0) to Day 49

Other adverse events by term

Limitations and caveats: This study was terminated by the Sponsor due to difficulty in participant recruitment, leading to a small number of participants enrolled. Due to early termination of the study, no efficacy data were collected.

• Study Protocol (PDF, 2018-03-08)
• Statistical Analysis Plan (PDF, 2019-10-11)