Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty in participant recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.
This was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which was oral aripiprazole or any other product). Eligible participants entered a screening period of up to 13 days. For participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis.
After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at Day 360. During this second, optional interventional period, participants may have started and stopped Abilify MyCite as clinically indicated.
A parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abilify MyCite | Experimental | Participants received Abilify MyCite during Months 1-3. During Months 4-6 use of Abilify MyCite was to be prohibited. Thereafter, at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) could have been initiated per the joint decision of the participants with their study physician. |
|
| Virtual Matched Controls | Active Comparator | Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abilify MyCite - Digital Medicine System | Combination Product | The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 | This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected. | Baseline through Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 | This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siyan Clinical Research | Santa Rosa | California | 95401 | United States | ||
| Psychiatric Addiction Curative/PACT Atlanta LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. Since the study was terminated early, no matching occurred.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Abilify MyCite | Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2018 | Oct 16, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Aripiprazole or other oral antipsychotics | Drug | For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD. |
|
| Baseline through Day 180 |
| Decatur |
| Georgia |
| 30030 |
| United States |
| Georgia Psychiatry and Sleep | Smyrna | Georgia | 30080 | United States |
| Kolade Research Institute | Las Vegas | Nevada | 89109 | United States |
| Signature Research Associates, Inc. | Fairlawn | Ohio | 44333 | United States |
| Received At Least 1 Dose Of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abilify MyCite | Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol. |
| BG001 | Virtual Matched Controls | Virtual matched controls were to receive treatment as usual (that is, any product other than Abilify MyCite, which could have been oral aripiprazole or any other product) throughout the duration of the trial. Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 | This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected. | Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination. | Posted | Baseline through Day 180 |
|
| ||||||||||||||||||||||
| Secondary | Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180 | This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected. | Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination. | Posted | Baseline through Day 180 |
|
Baseline (Day 0) to Day 49
The 2 enrolled participants both received Abilify MyCite. According to protocol, serious and other adverse events were not to be assessed for Virtual Matched Controls.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abilify MyCite | Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol. | 0 | 2 | 0 | 2 | 1 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDra 22.0 | Systematic Assessment |
|
This study was terminated by the Sponsor due to difficulty in participant recruitment, leading to a small number of participants enrolled. Due to early termination of the study, no efficacy data were collected.
Sponsor reserves the right to review, edit, and authorize publications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | +1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2019 | Oct 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|