DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

PHASE4UnknownINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

April 4, 2019

Primary Completion Date

January 31, 2021

Study Completion Date

November 30, 2021

Conditions
SchizophreniaMajor Depressive DisorderBi-Polar DisorderSchizo Affective Disorder
Interventions
COMBINATION_PRODUCT

ABILIFY MYCITE

Initiation of ABILIFY MYCITE will commence immediately, with subjects wearing the patch and using the smartphone app for a total of 3 months from baseline visit to the 3 month visit. Following the initial 90-days, the physician and patient may determine to use ABILIFY MYCITE anytime during the following 9 months. Following this period (up to 12 months), the subjects will not use ABILIFY MYCITE and return to standard care. A safety follow-up phone call will occur at 2 weeks after the 12 month/early termination (ET) visit. In addition, individuals in the ABILIFY MYCITE arm will evaluate satisfaction with the use of ABILIFY MYCITE.

Trial Locations (2)

27705

Durham VA Medical Center, Durham

77030

Michael E. DeBakey VA Medical Center, Houston

Sponsors
All Listed Sponsors
collaborator

Otsuka Pharmaceutical Development and Commercialization, Inc.

UNKNOWN

lead

Durham VA Medical Center

FED