Overview
CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Status:
Completed
Completed
Trial end date:
2020-05-06
2020-05-06
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a prospective study using customized adherence enhancement (CAE) and long-acting injectable (LAI) antipsychotic in 30 individuals with bipolar disorder (BD) at risk for treatment non-adherence. The CAE approach is expected to improve treatment adherence, as well as improve BD symptoms, functioning and treatment attitudes among subjects with bipolar disorder.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Martha SajatovicCollaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.Treatments:
Aripiprazole
Criteria
Inclusion Criteria:1. Individuals age 18 and older with BD Type 1 or 2 as confirmed by the Mini
International Psychiatric Inventory (MINI).
2. Known to have medication treatment adherence problems as identified by the Treatment
Routines Questionnaire (TRQ, 20% or more missed medications in past week or past
month)
3. Screening BPRS score of ≥ 36
4. Ability to be rated on psychiatric rating scales.
5. Willingness to take LAI
6. Currently in treatment or scheduled to receive treatment at a Community Mental Health
Clinic (CMHC) or other clinical setting able to provide mental health care during and
after study participation
7. Able to provide written, informed consent to study participation.
Exclusion Criteria:
1. Individuals on LAI immediately prior to study enrollment.
2. Individuals with known intolerance or resistance to either oral aripiprazole or LAI
formulation of aripiprazole
3. Prior or current treatment with clozapine
4. Medical condition or illness, which in the opinion of the research psychiatrist, would
interfere with the patient's ability to participate in the trial
5. Physical dependence on substances (alcohol or illicit drugs) likely to lead to
withdrawal reaction during the course of the study in the clinical opinion of the
treated research psychiatrist
6. Immediate risk of harm to self or others
7. Female who is currently pregnant or breastfeeding