NCT03892889

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

A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.

Detailed description

This study is designed to assess the difference between inpatient psychiatric hospitalization rates in participants 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 participants 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. Participants 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. Participants will enter a screening period (up to 45 days). If deemed eligible to participate, participants will enter an open-label Abilify MyCite® treatment prospective phase for up to 6 months. All participants 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 participants will be screened in order to enroll 320 participants and complete 224 participants. There was an interim analysis planned for the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Abilify MyCite®	Combination product of aripiprazole tablet embedded with sensor and wearable patch.

Timeline

• Start date: 2019-04-29
• Primary completion: 2020-08-12
• Completion: 2020-09-29
• First posted: 2019-03-27
• Last updated: 2021-09-05
• Results posted: 2021-09-05

Locations

68 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study