A Phase 4 interventional study of Abilify Maintena and Customized Adherence Enhancement (CAE) in Bipolar Disorder, Medication Adherence and Medication Non Adherence, sponsored by Martha Sajatovic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by Martha Sajatovic · Phase 4, Interventional, and Treatment
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's enrollment of 30 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →This is the only study on the registry with Martha Sajatovic as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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).
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline to Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screen to Week 24
. Individuals were recruited from an academic medical center and via outreach to community settings including community mental health clinics (CMHCs). Enrolled participants had self-reported adherence problems as identified by the TRQ (≥20% missed BD medications in past week or past month), a screening Brief Psychiatric Rating Scale15 score ≥36, willingness to take LAI, and were in treatment at a CMHC or other clinical setting. Participants were adults ≥ age 18 with Type 1 or Type 2 BD.
| Milestone | CAE-L |
|---|---|
| Started | 30 |
| Completed | 27 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
| Milestone | CAE-L |
|---|---|
| Started | 27 |
| Completed | 26 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Milestone | CAE-L |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | CAE-L |
|---|---|
| Started | 25 |
| Completed | 23 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
| Milestone | CAE-L |
|---|---|
| Started | 23 |
| Completed | 22 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Milestone | CAE-L |
|---|---|
| Started | 22 |
| Completed | 21 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | CAE-L |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
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.
| percentage of missed BD medications | CAE-L |
|---|---|
| Screen | 50.1 ± 24.8 |
| Baseline | 37.5 ± 30.0 |
| Week 24 | 16.9 ± 26.97 |
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.
| percentage of missed BD medications | CAE-L |
|---|---|
| Screen | 40.6 ± 23.7 |
| Baseline | 29.4 ± 21.6 |
| Week 24 | 19.2 ± 24.5 |
LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time).
| percentage of adherence | CAE-L |
|---|---|
| LAI Injection Adherence | 100 ± 0 |
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.
| score on a scale | CAE-L |
|---|---|
| Baseline | 36.4 ± 7.4 |
| Week 24 | 24.9 ± 5.7 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 13.2 ± 6.2 |
| Baseline | 10.4 ± 5.6 |
| Week 24 | 5.6 ± 4.3 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 24.5 ± 5.7 |
| Baseline | 18.1 ± 9.4 |
| Week 24 | 7.95 ± 8.2 |
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
| score on a scale | CAE-L |
|---|---|
| Screen | 4.6 ± 0.5 |
| Baseline | 4.1 ± 0.6 |
| Week 24 | 2.8 ± 0.8 |
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
| score on a scale | CAE-L |
|---|---|
| Screen | 7.2 ± 1.9 |
| Week 24 | 8.1 ± 1.4 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 7.9 ± 3.3 |
| Week 24 | 4.0 ± 3.4 |
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.
| score on a scale | CAE-L |
|---|---|
| Baseline | 51.9 ± 8.1 |
| Week 24 | 70.8 ± 8.1 |
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
| score on a scale | CAE-L |
|---|---|
| Baseline | 53.5 ± 8.1 |
| Week 24 | 70.7 ± 7.9 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 52.9 ± 16.1 |
| Week 24 | 70.7 ± 8.4 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 47.3 ± 12.4 |
| Week 24 | 68.5 ± 13.8 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 22.4 ± 4.2 |
| Week 24 | 22.1 ± 6.3 |
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.
| score on a scale | CAE-L |
|---|---|
| Screen | 46.8 ± 16.8 |
| Week 24 | 34.8 ± 18.7 |
Collected over Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAE-L | 0/30 (0%) | 0/30 (0%) | 23/30 (76.7%) |
| Event | CAE-L |
|---|---|
| Injection site pain or reactionSkin and subcutaneous tissue disorders | 7/23 |
| DrowsinessNervous system disorders | 7/23 |
| TremorNervous system disorders | 6/23 |
| Sexual dysfunctionReproductive system and breast disorders | 3/23 |
| DroolingGeneral disorders | 2/23 |
| Muscle Movement complaintsMusculoskeletal and connective tissue disorders | 2/23 |
| Weight gainMetabolism and nutrition disorders | 2/23 |
| Age, Continuous(years) | CAE-L |
|---|---|
| Mean | 49.47 ± 9.28 |
| Sex: Female, Male(Participants) | CAE-L |
|---|---|
| Female | 13 |
| Male | 17 |
| Race/Ethnicity, Customized(Participants) | CAE-L |
|---|---|
| White | 9 |
| Black or African American | 17 |
| Other or Multiracial | 4 |
| Race/Ethnicity, Customized(Participants) | CAE-L |
|---|---|
| Hispanic | 1 |
| Non Hispanic | 29 |
| Marital Status(Participants) | CAE-L |
|---|---|
| Single, never married | 17 |
| Married | 1 |
| Separated/Divorced/Widowed | 12 |
| Mean Years of Education Attained(years) | CAE-L |
|---|---|
| Mean | 13.63 ± 2.85 |
| Occupation Status(Participants) | CAE-L |
|---|---|
| Full time employment/homemaker | 0 |
| Part time employment/ homemaker or student | 4 |
| Unemployed or on disability | 25 |
| Other | 1 |
| Number of Participants Who Live Alone(Participants) | CAE-L |
|---|---|
| Count of participants | 16 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Aripiprazole