Last updated on March 2020

A Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03892889

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Siyan Clinical Research

Santa Rosa, CA United States
2.21miles
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Recruitment Status: Open


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