CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Condition: Bipolar Disorder; Medication Adherence; Medication Non Adherence
MeSH terms: Bipolar Disorder
Intervention: Abilify Maintena; Customized Adherence Enhancement (CAE)
Intervention description: 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.; 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).
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antipsychotic Drugs; Antipsychotics; Injectables; Long Acting Injectable Antipsychotic; Bipolar Disorder; Medication Adherence; Medication Non-Adherence

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.
    

Eligibility 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 the Brief Psychiatric Rating Scale (BPRS) score of ≥ 36

          4. Ability to be rated on psychiatric rating scales.

          5. Willingness to take long-acting injectable antipsychotic medication (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