Schizophrenia Clinical Trial
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
Verified date | October 2019 |
Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 17, 2018 |
Est. primary completion date | October 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 63 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Psychiatric Addiction Curative/PACT Atlanta LLC | Decatur | Georgia |
United States | Signature Research Associates, Inc. | Fairlawn | Ohio |
United States | Kolade Research Institute | Las Vegas | Nevada |
United States | Siyan Clinical Research | Santa Rosa | California |
United States | Georgia Psychiatry and Sleep | Smyrna | Georgia |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To 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. | Baseline through Day 180 | |
Secondary | 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 | 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. | Baseline through Day 180 |
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