CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

May 6, 2020

Study Completion Date

May 6, 2020

Conditions
Bipolar DisorderMedication AdherenceMedication Non Adherence
Interventions
DRUG

Abilify Maintena

Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.

BEHAVIORAL

Customized Adherence Enhancement (CAE)

CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

lead

Martha Sajatovic

OTHER

NCT03408873 - CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL) | Biotech Hunter | Biotech Hunter