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
Schizophrenia, Bipolar 1 Disorder, Major Depressive Disorder
About this trial
This is an interventional health services research trial for Schizophrenia focused on measuring Digital Medicine System
Eligibility Criteria
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.
Sites / Locations
- Siyan Clinical Research
- Psychiatric Addiction Curative/PACT Atlanta LLC
- Georgia Psychiatry and Sleep
- Kolade Research Institute
- Signature Research Associates, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Abilify MyCite
Virtual Matched Controls
Participants received Abilify MyCite during Months 1-3. During Months 4-6 use of Abilify MyCite was to be prohibited. Thereafter, 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.
Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. 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.