Phase 4
Completed N=30
CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Bipolar Disorder · Medication Adherence · Medication Non Adherence
Source: ClinicalTrials.gov NCT03408873 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Change in Tablets Routine Questionnaire (TRQ, Past Week) — 50.1; 37.5; 16.9 percentage of missed BD medications — p=<0.001
◆ Published Evidence
Emerging
12citations · ~2 / year
Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder.
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.
Linked Publications
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Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tablets Routine Questionnaire (TRQ, Past Week) |
50.1; 37.5; 16.9 | <0.001 sig |
| PRIMARY Change in Tablets Routine Questionnaire (TRQ, Past Month) |
40.6; 29.4; 19.2 | 0.0599 |
| PRIMARY LAI Injection Adherence |
100 | — |
| SECONDARY Change in the Brief Psychiatric Rating Scale (BPRS) Score |
36.4; 24.9 | <0.001 sig |
| SECONDARY Change in Young Mania Rating Scale (YMRS) Score |
13.2; 10.4; 5.6 | <0.001 sig |
| SECONDARY Change in Montgomery Asberg Rating Scale (MADRS) Score |
24.5; 18.1; 7.95 | <0.001 sig |
| SECONDARY Change in Clinical Global Impressions (CGI) Score |
4.6; 4.1; 2.8 | <0.001 sig |
| SECONDARY Change in Drug Attitude Inventory (DAI) Score |
7.2; 8.1 | 0.0566 |
| SECONDARY Change in Attitude Towards Medication Questionnaire (AMSQ) Score |
7.9; 4.0 | <0.001 sig |
| SECONDARY Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score |
51.9; 70.8 | <0.001 sig |
| SECONDARY Change in Global Assessment of Functioning (GAF) Score |
53.5; 70.7 | <0.001 sig |
| SECONDARY Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score |
52.9; 70.7 | <0.001 sig |
| SECONDARY Change in The Self-Report Habit Index (SRHI) Score |
47.3; 68.5 | <0.001 sig |
| SECONDARY Change in Communication Styles Scale Score |
22.4; 22.1 | 0.73 |
| SECONDARY Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score |
46.8; 34.8 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03408873) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.