Clinical Trial 43431

Oakland, CA 94607


Summary:

To compare inpatient psychiatric hospitalization rates while subjects are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite. This trial will include male and female subjects who are 18 to 65 years old and diagnosed with schizophrenia. The trial will be conducted at 75 sites in the United States, with the a target of enrolling 320 subjects. Subject participation is approximately 8 months, including a 45-day screening period, a required 3 months (Months 1 to 3) of Abilify MyCite treatment. This will be followed to either a change back to standard-of-care antipsychotic treatment or remain on Abilify MyCite for an additional 3 months (Months 4-6). All subjects who complete or withdraw from the trial while on Abilify MyCite will receive a telephone call for safety follow-up approximately 30 days after their last trial visit.



Inclusion Criteria:

  • Subject must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
  • Male and female subjects 18 to 65 years of age
  • Subject must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite app. A subject with a smartphone that is not compatible with the Abilify MyCite app will be offered a loaner phone for the trial period.
  • Clinical diagnosis of schizophrenia and able to ingest oral medication
  • Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
  • Subjects currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
  • Subjects are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
  • Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems


Qualified Participants May Receive:

Monetary compensation and study-related care at no cost to the participant


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.