Trial Outcomes & Findings for Fluoxetine vs Aripiprazole Comparative Trial (FACT) (NCT NCT02357849)

NCT ID: NCT02357849

Last Updated: 2023-11-15

Results Overview

Time to either all-cause-discontinuation or need to add another psychotropic agent

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

24 weeks

Results posted on

2023-11-15

Participant Flow

outpatient clinic

Participant milestones

Participant milestones
Measure	Aripiprazole Intervention arm	Fluoxetine Active control arm
Overall Study STARTED	4	5
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole Intervention arm	Fluoxetine Active control arm
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=4 Participants Intervention arm	Fluoxetine n=5 Participants Active control arm	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=39 Participants	5 Participants n=41 Participants	9 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	15.5 years STANDARD_DEVIATION 1.3 • n=39 Participants	16.0 years STANDARD_DEVIATION 1.7 • n=41 Participants	15.8 years STANDARD_DEVIATION 1.6 • n=35 Participants
Sex: Female, Male Female	1 Participants n=39 Participants	2 Participants n=41 Participants	3 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=39 Participants	3 Participants n=41 Participants	6 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) White	1 Participants n=39 Participants	2 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	4 participants n=39 Participants	5 participants n=41 Participants	9 participants n=35 Participants
Treatment Failure	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Data was not collected

Time to either all-cause-discontinuation or need to add another psychotropic agent

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Data was not collected

Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Data was not collected

Number of patients with any adverse effects based on spontaneous report

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Data was not collected

Change in social and role functioning scores (range: 0-10, higher sores = better outcome)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Data was not collected

Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christoph Correll

Northwell Health

Phone: 718-470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place