A Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
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|ClinicalTrials.gov Identifier: NCT03892889|
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Combination Product: ABILIFY MYCITE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: ABILIFY MYCITE
Subjects will receive Abilify MyCite for 3 months (Months 1 to 3) and 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 (eg, oral atypical antipsychotics or a long acting injectable [LAI]) for the duration of treatment.
Combination Product: ABILIFY MYCITE
Abilify MyCite tracks drug ingestion and is composed of an Aripiprazole tablet embedded with a sensor (Abilify MyCite). Abilify MyCite Patch (wearable) detects the signal from the sensor after ingestion and transmits data to a smartphone. Abilify MyCite App, a smartphone app, which is used with a compatible smartphone to display medication ingestion information for the subject. Web-based portal or dashboard for investigators and caregivers.
- Inpatient psychiatric hospitalization [ Time Frame: 3 months ]Comparison of inpatient psychiatric hospitalization rates of subjects on oral standard-of-care antipsychotic treatment and switching to Abilify MyCite.
- Improved adherence based on overall proportion of days covered with Abilify MyCite versus retrospective oral atypical antipsychotics. [ Time Frame: Retrospective - Months 1-3 and Prospective - Months 1-3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892889
|Contact: Project Manageremail@example.com|