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

NCT03408873 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: I0113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Medication Adherence; Medication Non Adherence

Keywords

Antipsychotic Drugs; Antipsychotics; Injectables; Long Acting Injectable Antipsychotic; Bipolar Disorder; Medication Adherence; Medication Non-Adherence

Outcome Measures

Primary Outcomes (3)

• Change in Tablets Routine Questionnaire (TRQ, Past Week)

  Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment. The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence.

  Screen to Week 24

• Change in Tablets Routine Questionnaire (TRQ, Past Month)

  Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.

  Screen to Week 24

• LAI Injection Adherence

  LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time).

  Baseline to Week 24

Secondary Outcomes (12)

• Change in the Brief Psychiatric Rating Scale (BPRS) Score

  Baseline to Week 24

• Change in Young Mania Rating Scale (YMRS) Score

  Screen to Week 24

• Change in Montgomery Asberg Rating Scale (MADRS) Score

  Screen to Week 24

• Change in Clinical Global Impressions (CGI) Score

  Screen to Week 24

• Change in Drug Attitude Inventory (DAI) Score

  Screen to Week 24

Study Arms (1)

Patient Noncompliance

EXPERIMENTAL

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

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

Interventions

Abilify Maintena DRUG

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.

Patient Noncompliance

Customized Adherence Enhancement (CAE) BEHAVIORAL

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).

Patient Noncompliance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 18 and older with BD Type 1 or 2 as confirmed by the Mini International Psychiatric Inventory (MINI).
• 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)
• Screening the Brief Psychiatric Rating Scale (BPRS) score of ≥ 36
• Ability to be rated on psychiatric rating scales.
• Willingness to take long-acting injectable antipsychotic medication (LAI)
• 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
• Able to provide written, informed consent to study participation.

You may not qualify if:

• Individuals on LAI immediately prior to study enrollment.
• Individuals with known intolerance or resistance to either oral aripiprazole or LAI formulation of aripiprazole
• Prior or current treatment with clozapine
• Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
• 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
• Immediate risk of harm to self or others
• Female who is currently pregnant or breastfeeding

Sponsors & Collaborators

• Martha Sajatovic: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 34534421 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Medication Adherence

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study had a number of limitations including small sample, non-controlled design, and single-site setting. An additional limitation is that adherence was based upon self-report, which has potential to under-count missed medication. The improvement in adherence behaviors immediately after screen (and before CAE was administered) may possibly reflect a Hawthorne effect which could have obscured improvement in CAE-related change.

Results Point of Contact

• Title: Joy Yala, MPH
• Organization: Case Western Reserve University and University Hospitals Cleveland Medical Center

jxy790@case.edu

216-368-0783

Study Officials

• Martha Sajatovic, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 24, 2018
• Study Start: April 1, 2018
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-01

Locations

US (1)