Clinical trial NCT03408873: CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Official title: Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Medication Adherence
Medication Non Adherence
Keywords: Antipsychotic Drugs
Antipsychotics
Injectables
Long Acting Injectable Antipsychotic
Bipolar Disorder
Medication Adherence
Medication Non-Adherence
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Development & Commercialization, Inc.
First posted: 2018-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Tablets Routine Questionnaire (TRQ, Past Week)
timeFrame: Screen to Week 24
measure: Change in Tablets Routine Questionnaire (TRQ, Past Month)
timeFrame: Screen to Week 24
measure: LAI Injection Adherence
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change in the Brief Psychiatric Rating Scale (BPRS) Score
timeFrame: Baseline to Week 24
measure: Change in Young Mania Rating Scale (YMRS) Score
timeFrame: Screen to Week 24
measure: Change in Montgomery Asberg Rating Scale (MADRS) Score
timeFrame: Screen to Week 24
measure: Change in Clinical Global Impressions (CGI) Score
timeFrame: Screen to Week 24
measure: Change in Drug Attitude Inventory (DAI) Score
timeFrame: Screen to Week 24
measure: Change in Attitude Towards Medication Questionnaire (AMSQ) Score
timeFrame: Screen to Week 24
measure: Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
timeFrame: Baseline to Week 24
measure: Change in Global Assessment of Functioning (GAF) Score
timeFrame: Baseline to Week 24
measure: Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score
timeFrame: Screen to Week 24
measure: Change in The Self-Report Habit Index (SRHI) Score
timeFrame: Screen to Week 24
measure: Change in Communication Styles Scale Score
timeFrame: Screen to Week 24
measure: Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score
timeFrame: Screen to Week 24
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sajatovic M, Levin JB, Ramirez LF, Cassidy KA, McNamara N, Fuentes-Casiano E, Wilson B, Appling D, S FB. Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder. Prim Care Companion CNS Disord. 2021 Sep 16;23(5):20m02888. doi: 10.4088/PCC.20m02888.