A 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
Otsuka Pharmaceutical Development & Commercialization, Inc.
A pragmatic clinical trial (Main Study) to assess the difference between all-cause
hospitalizations in patients using Abilify MyCite versus virtual matched controls. Eligible
patients will enter a screening period of up to 13 days. At enrollment, patients will receive
treatment with Abilify MyCite for 3 months and discontinue the use of Abilify MyCite during
the following 3 months (and the patient continues with oral aripiprazole or other appropriate
treatment). Thereafter, the patient has the option to start and stop Abilify MyCite (up to 6
months of Abilify MyCite) per the joint decision of the patients with their study physician.
A parallel exploratory study will utilize a different set of physicians and patients from the
main study. Procedures for the exploratory study will be similar to those in the Main Study,
with the exception that there will be 1-month intervals of Abilify MyCite use (and 1-month
intervals of prohibition of Abilify MyCite use).
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