Clinical Trial 43375

share

Garden Grove, CA 92845


Study 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.

This is a phase 3b, open-label, prospective, clinical trial designed to assess the difference between inpatient psychiatric hospitalization rates in subjects on oral standard-of-care antipsychotic treatment(s) for a period of 6 months followed by a switch to Abilify MyCite for a period of 3 months (Months 1 to 3). At the Month 3 visit, the investigator should decide if subjects will continue on Abilify MyCite for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment for the duration of treatment. This trial will include male and female subjects who are 18 to 65 years of age, inclusive, with a diagnosis of schizophrenia. Subjects must have had at least 1 inpatient psychiatric hospitalization within 4 years (48 months) and must have been prescribed oral antipsychotics for at least 6 months or longer prior to screening. Subjects will enter a screening period (up to 45 days). If deemed eligible to participate, subjects will enter an open-label Abilify MyCite treatment prospective phase for up to 6 months. 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. The trial will be conducted at 75 sites in the United States, 493 subjects will be screened in order to enroll 320 subjects and complete 224 subjects.



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

Exclusion Criteria:

  • Females who are breast-feeding and/or who are pregnant
  • Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite.
  • Any subject who participated in another clinical trial within 30 days of enrollment
  • Subjects who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
  • Subjects with a current DSM-5 diagnosis other than schizophrenia
  • Subject with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor


Qualified Participants May Receive:

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


Study is Available At:

CNS - Collaborative Neuroscience
12772 Valley View St.
Garden Grove, CA 92845
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

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.