Trial Outcomes & Findings for A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder (NCT NCT03643159)

Last Updated: 2019-11-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Baseline through Day 180

Results posted on

2019-11-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study Received At Least 1 Dose Of Study Drug	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline through Day 180

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 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.

Outcome measures

Outcome data not reported

Adverse Events

Abilify MyCite

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abilify MyCite n=2 participants at risk Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • 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.

Additional Information

Global Clinical Development

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: +1-609-524-6788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right to review, edit, and authorize publications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Abilify MyCite n=2 Participants Participants received Abilify MyCite during Months 1-3. The treatment medication dose decision was determined by the study physicians independent from the protocol.	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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Age, Categorical Between 18 and 65 years	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Age, Categorical >=65 years	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Sex: Female, Male Female	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Sex: Female, Male Male	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) Asian	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) Black or African American	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) White	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) More than one race	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
Race (NIH/OMB) Unknown or Not Reported	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.	0 Participants Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.