Bipolar DisorderPhase 4NCT03408873
CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
A Phase 4 study testing Abilify Maintena and Customized Adherence Enhancement (CAE) in people with Bipolar Disorder and Medication Adherence, run by Martha Sajatovic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Medication Adherence, Medication Non Adherence
- What is being tested?
- Abilify Maintena and Customized Adherence Enhancement (CAE)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 6 May 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change
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.
Read the 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.
- Being tested
- Abilify Maintena, Customized Adherence Enhancement (CAE)
- Keywords
- Antipsychotic Drugs, Antipsychotics, Injectables, Long Acting Injectable Antipsychotic, Bipolar Disorder, Medication Adherence, Medication Non-Adherence
- Medical subject headings
- Bipolar Disorder, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abilify MaintenaDrug
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.
Customized Adherence Enhancement (CAE)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Patient Noncompliance | Experimental | Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention Receives: Drug: Abilify Maintena; Behavioral: Customized Adherence Enhancement (CAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline to Week 24
Secondary outcomes (12)
Change in the Brief Psychiatric Rating Scale (BPRS) Score
The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Measured: Baseline to Week 24
Change in Young Mania Rating Scale (YMRS) Score
The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: Screen to Week 24
Change in Montgomery Asberg Rating Scale (MADRS) Score
The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: Screen to Week 24
Change in Clinical Global Impressions (CGI) Score
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Measured: Screen to Week 24
Change in Drug Attitude Inventory (DAI) Score
DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications
Measured: Screen to Week 24
Change in Attitude Towards Medication Questionnaire (AMSQ) Score
A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored "0", while responses which suggest negative attitudes towards medications are scored "1". The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers.
Measured: Screen to Week 24
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning.
Measured: Baseline to Week 24
Change in Global Assessment of Functioning (GAF) Score
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Measured: Baseline to Week 24
Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score
The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management.
Measured: Screen to Week 24
Change in The Self-Report Habit Index (SRHI) Score
The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits.
Measured: Screen to Week 24
Change in Communication Styles Scale Score
The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style.
Measured: Screen to Week 24
Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score
The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking.
Measured: Screen to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Apr 2018
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martha Sajatovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408873
- Sponsor's protocol ID
- I0113
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2018
- Last updated
- 17 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34534421
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change
- ClinicalTrials.gov ID
- NCT03408873
- Acronym / sponsor ID
- I0113
- Keywords
- Antipsychotic Drugs, Antipsychotics, Injectables, Long Acting Injectable Antipsychotic, Bipolar Disorder, Medication Adherence, Medication Non-Adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Martha SajatovicUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Noncompliance | Experimental | Drug: Abilify Maintena, Behavioral: Customized Adherence Enhancement (CAE)Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abilify MaintenaDrug 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. | Drug | Patient Noncompliance |
| Customized Adherence Enhancement (CAE)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). | Behavioural | Patient Noncompliance |
Primary outcome
Change in Tablets Routine Questionnaire (TRQ, Past Week)
Time frame: Screen to Week 24
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.
Change in Tablets Routine Questionnaire (TRQ, Past Month)
Time frame: Screen to Week 24
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.
LAI Injection Adherence
Time frame: Baseline to Week 24
LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time).
12 secondary outcomes
Change in the Brief Psychiatric Rating Scale (BPRS) Score
Time frame: Baseline to Week 24
Change in Young Mania Rating Scale (YMRS) Score
Time frame: Screen to Week 24
Change in Montgomery Asberg Rating Scale (MADRS) Score
Time frame: Screen to Week 24
Change in Clinical Global Impressions (CGI) Score
Time frame: Screen to Week 24
Change in Drug Attitude Inventory (DAI) Score
Time frame: Screen to Week 24
Change in Attitude Towards Medication Questionnaire (AMSQ) Score
Time frame: Screen to Week 24
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
Time frame: Baseline to Week 24
Change in Global Assessment of Functioning (GAF) Score
Time frame: Baseline to Week 24
Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score
Time frame: Screen to Week 24
Change in The Self-Report Habit Index (SRHI) Score
Time frame: Screen to Week 24
Change in Communication Styles Scale Score
Time frame: Screen to Week 24
Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score
Time frame: Screen to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34534421Sajatovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abilify Maintena and Customized Adherence Enhancement (CAE) in people with Bipolar Disorder and Medication Adherence, run by Martha Sajatovic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tablets Routine Questionnaire (TRQ, Past Week) (time frame: Screen to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03408873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022; AzTrials last refreshed its copy on 3 Nov 2026.