NCT03408873|CompletedPhase 4ResultsDMCFDA Drug
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Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change
Sponsor study identifier
interventional
30
1 country
1
Study Start
April 1, 2018
Actual (reported)Primary Completion
May 6, 2020
Actual (reported)Study Completion
May 6, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2018
Actual (reported)January 24, 2018
Actual (reported)April 1, 2018
Actual (reported)May 6, 2020
Actual (reported)May 6, 2020
Actual (reported)February 17, 2022
Actual (reported)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).
Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention
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.
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).
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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.
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.
Martha Sajatovic, MD
University Hospitals Cleveland Medical Center
30 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2018
First Posted
January 24, 2018
Study Start
April 1, 2018
Actual (reported)Baseline to Week 24
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 6, 2020
Actual (reported)Study Completion
May 6, 2020
Actual (reported)Last Updated
February 17, 2022
Results First Posted
February 17, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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