Status:
COMPLETED
CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Lead Sponsor:
Martha Sajatovic
Collaborating Sponsors:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Bipolar Disorder
Medication Adherence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03408873
Start Date
April 1 2018
End Date
May 6 2020
Last Update
February 17 2022
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106