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

Martha Sajatovic

Status and phase: Completed; Phase 4

Conditions: Medication Adherence; Bipolar Disorder; Medication Non Adherence

Treatments: Behavioral: Customized Adherence Enhancement (CAE); Drug: Abilify Maintena

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03408873

I0113

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patient Noncompliance

Experimental group

Description:

Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention

Treatment:

Behavioral: Customized Adherence Enhancement (CAE)

Drug: Abilify Maintena