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

Oral Abilify (aripiprazole) is effective in the treatment of patients with BD when prescribed
as an acute anti-manic agent and for the maintenance treatment of bipolar disorder. Abilify
Maintena is an intramuscular (IM) depot formulation of oral aripiprazole (Abilify). Abilify
Maintena appears to be as effective as standard oral Abilify and may maximize patient
adherence. Recent clinical trials suggest that Abilify Maintena is effective for the
treatment of patients with BD.

Customized Adherence Enhancement (CAE) is a brief behavioral intervention that improves
adherence approximately 30% more than an educational control in adults with BD. The CAE
program is a brief, practical intervention consisting of a series of up to four psychosocial
treatment modules based upon an adult's unique adherence barriers: 1) Psychoeducation on BD
Medications; 2) Communication with Providers; 3) Strategies to Enhance Medication Routines;
and 4) Targeting Substance Use Problems with Modified Motivational Enhancement Therapy.
Multiple studies conducted by these investigators has shown that CAE is effective in in
treating poorly adherent BD adults.

In addition, studies by these investigators have shown that combining LAI + CAE dramatically
improves adherence, symptoms and functional outcomes in people with schizophrenia and
schizoaffective disorder. In summary, LAI can maximize medication adherence, while CAE
addresses individual barriers to sustained adherence and behavioral change. Combining LAI +
CAE improves adherence, symptoms and functioning in high-risk people with primary psychotic
disorders. The proposed project will test the efficacy of combining Abilify Maintena with CAE
to help improve outcomes in poorly adherent patients with BD. Pilot data suggest that
adherence with concomitantly prescribed psychotropic drugs improves with LAI + CAE. The
findings have particular relevance to BD because many BD patients are on concomitant oral
psychotropic drugs in addition to antipsychotic. Thus, it is expected that combining CAE with
LAI will lead to a "halo effect" in that these BD patients will engage in their own care more
broadly.

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