Trial Outcomes & Findings for Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (NCT NCT02717130)

NCT ID: NCT02717130

Last Updated: 2020-04-13

Results Overview

Psychiatric re-hospitalization were planning to be assessed using hospital admission records. Study stopped due to lack of enrollment.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-04-13

Participant Flow

Participant milestones

Measure	Aripiprazole (Abilify Maintena) Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Aripiprazole (Abilify Maintena) Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Physician Decision	1
Overall Study Study Closure	4

Baseline Characteristics

Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

Baseline characteristics by cohort

Measure	Aripiprazole (Abilify Maintena) n=8 Participants Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Age, Continuous	32.84 years STANDARD_DEVIATION 8.69 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Severity of Illness Moderately Ill	1 Participants n=5 Participants
Severity of Illness Markedly Ill	5 Participants n=5 Participants
Severity of Illness Severely Ill	2 Participants n=5 Participants
Body Mass Index (BMI)	29.08 kilograms per squared meter STANDARD_DEVIATION 7.88 • n=5 Participants
Height	167.48 centimeters STANDARD_DEVIATION 13.40 • n=5 Participants
Weight	80.02 kilograms STANDARD_DEVIATION 16.36 • n=5 Participants
Total Cholesterol	169.75 milligrams per deciliter STANDARD_DEVIATION 32.38 • n=5 Participants
Triglycerides	97.63 milligrams per deciliter STANDARD_DEVIATION 58.34 • n=5 Participants
High-Density Lipoproteins (HDL) Cholesterol	66.25 milligrams per deciliter STANDARD_DEVIATION 33.97 • n=5 Participants
Low-Density Lipoproteins (LDL) Cholesterol	84.13 milligrams per deciliter STANDARD_DEVIATION 28.38 • n=5 Participants
Hemoglobin A1c (HbA1c)	5.11 percent STANDARD_DEVIATION 0.28 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Data was not collected. The number of participants analyzed is 0 because the study was stopped due to lack of enrollment.

Psychiatric re-hospitalization were planning to be assessed using hospital admission records. Study stopped due to lack of enrollment.

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole (Abilify Maintena)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aripiprazole (Abilify Maintena) n=8 participants at risk Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Psychiatric disorders Psychiatric hospitalization	12.5% 1/8 • Number of events 2 • The time period over which adverse event data were collected was 30 days.
Nervous system disorders Seizure	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
General disorders Generalized weakness	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.

Other adverse events

Measure	Aripiprazole (Abilify Maintena) n=8 participants at risk Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Cardiac disorders Prolonged QTc Interval	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
Nervous system disorders Insomnia	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
Skin and subcutaneous tissue disorders Cellulitis	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
General disorders Sialorrhea	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
General disorders Injection Site Pain	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.
Nervous system disorders Akathisia	12.5% 1/8 • Number of events 1 • The time period over which adverse event data were collected was 30 days.

Additional Information

John W. Newcomer, M.D., President & CEO

Thriving Mind South Florida

Phone: 305-860-0653

Email: jnewcomer@thrivingmind.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place