Schizophrenia
Conditions
Brief summary
To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
Detailed description
This study is designed to assess the difference between inpatient psychiatric hospitalization rates in participants on oral standard-of-care antipsychotic treatment(s) for a period of 6 months followed by a switch to Abilify MyCite® for a period of 3 months (Months 1 to 3). At the Month 3 visit, the investigator should decide if participants will continue on Abilify MyCite® for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment for the duration of treatment. Participants must have had at least 1 inpatient psychiatric hospitalization within 4 years (48 months) and must have been prescribed oral antipsychotics for at least 6 months or longer prior to screening. Participants will enter a screening period (up to 45 days). If deemed eligible to participate, participants will enter an open-label Abilify MyCite® treatment prospective phase for up to 6 months. All participants who complete or withdraw from the trial while on Abilify MyCite® will receive a telephone call for safety follow-up approximately 30 days after their last trial visit. The trial will be conducted at 75 sites in the United States, 493 participants will be screened in order to enroll 320 participants and complete 224 participants. There was an interim analysis planned for the study.
Interventions
COMBINATION_PRODUCTAbilify MyCite®
Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English. * Male and female participants 18 to 65 years of age. * Participants must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite® app. Participants with a smartphone, that is not compatible with the Abilify MyCite® app will be offered a loaner phone for the trial period. * Clinical diagnosis of schizophrenia and able to ingest oral medication. * Positive and Negative Syndrome Scale (PANSS) total score between 60-90. * Participants currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer. * Participants are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial. * Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems.
Exclusion criteria
* Females who are breast-feeding and/or who are pregnant. * Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®. * Any participants who participated in another clinical trial within 30 days of enrollment. * Participants who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase. * Participants with a current DSM-5 diagnosis other than schizophrenia. * Participants with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Inpatient Psychiatric Hospitalization | Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3) | Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days With Improved Adherence | Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months) | Improved adherence was based on the overall proportion of days covered (PDC) in participants compliant with study drug administration in the Prospective period on Prospective Abilify MyCite® versus Retrospective Period on oral atypical antipsychotics. PDC was calculated as = number of days 'covered' in the Respective Period/number of days in the period \* 100. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 58 investigative sites in the United States from 29 April 2019 to 12 August 2020.
Pre-assignment details
Participants who were on oral standard-of-care antipsychotic treatments for a period of 6 months prior to Baseline (Day 1) were assessed retrospectively and were enrolled in the Prospective Period on Day 1 to receive Abilify MyCite® for a period of 3 months (Months 1 to 3) and to continue with same treatment or standard of care up to Month 6.
Participants by arm
| Arm | Count |
|---|---|
| Abilify MyCite® Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable. | 277 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 17 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 46 |
| Overall Study | Non-compliance with study drug | 22 |
| Overall Study | Physician Decision | 8 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Deviation | 3 |
| Overall Study | Reason not Specified | 5 |
| Overall Study | Study Terminated by Sponsor | 50 |
| Overall Study | Withdrawal by Caregiver | 1 |
| Overall Study | Withdrawal by Subject | 50 |
Baseline characteristics
| Characteristic | Abilify MyCite® |
|---|---|
| Age, Continuous | 44.2 Years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 223 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 167 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 98 Participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 277 |
| other Total, other adverse events | 0 / 277 |
| serious Total, serious adverse events | 6 / 277 |
Outcome results
Primary
Percentage of Participants With Inpatient Psychiatric Hospitalization
Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.
Time frame: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
Population: Modified Intent-to-Treat (mITT) Sample included data from all participants entering the prospective phase who have completed the first 3-months of dosing on Abilify MyCite®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abilify MyCite® | Percentage of Participants With Inpatient Psychiatric Hospitalization | 0.0 percentage of participants |
Secondary
Percentage of Days With Improved Adherence
Improved adherence was based on the overall proportion of days covered (PDC) in participants compliant with study drug administration in the Prospective period on Prospective Abilify MyCite® versus Retrospective Period on oral atypical antipsychotics. PDC was calculated as = number of days 'covered' in the Respective Period/number of days in the period \* 100.
Time frame: Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)
Population: ITT Sample included all enrolled sample who met the study inclusion/exclusion criteria and who are intended to receive study medication in the Prospective Phase. Overall number analyzed is the number of participants with confirmed retrospective prescription data to conduct the PDC calculation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abilify MyCite® | Percentage of Days With Improved Adherence | PDC in Retrospective Period | 51.0 percentage of days | Standard Deviation 37.9 |
| Abilify MyCite® | Percentage of Days With Improved Adherence | PDC in Prospective Period | 77.5 percentage of days | Standard Deviation 31.8 |
p-value: <0.0001paired t-test