Clinical trial NCT03643159: 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
Official title: A Multicenter, 180-day Pragmatic Clinical Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Bipolar 1 Disorder
Major Depressive Disorder
Keywords: Digital Medicine System
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

Detailed description: 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.

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.

Primary outcomes:
measure: Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180
timeFrame: Baseline through Day 180
Secondary outcomes:
measure: 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
timeFrame: Baseline through Day 180
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Siyan Clinical Research
state: California
city: Decatur
country: United States
facility: Psychiatric Addiction Curative/PACT Atlanta LLC
state: Georgia
city: Smyrna
country: United States
facility: Georgia Psychiatry and Sleep
state: Georgia
city: Las Vegas
country: United States
facility: Kolade Research Institute
state: Nevada
city: Fairlawn
country: United States
facility: Signature Research Associates, Inc.
state: Ohio
Study officials:
References: