Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Sponsor

Northwell Health (Other)

Overall Status

Terminated

CT.gov ID

NCT02357849

Collaborator

(none)

Enrollment

Location

Arms

93.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.

Condition or Disease	Intervention/Treatment	Phase
Attenuated Psychosis Syndrome	Drug: Aripiprazole Drug: Fluoxetine	Phase 4

Detailed Description

To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Apr 4, 2022

Actual Study Completion Date :

Apr 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aripiprazole To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg).	Drug: Aripiprazole see arm description Other Names: Abilify
Active Comparator: Fluoxetine To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg).	Drug: Fluoxetine see arm description Other Names: Prozac

Arm

Intervention/Treatment

Active Comparator: Aripiprazole

To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg).

Drug: Aripiprazole

see arm description

Other Names:

Abilify

Active Comparator: Fluoxetine

To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg).

Drug: Fluoxetine

see arm description

Other Names:

Prozac

Outcome Measures

Primary Outcome Measures

Time to treatment failure [24 weeks]
Time to either all-cause-discontinuation or need to add another psychotropic agent

Secondary Outcome Measures

Change in Prodromal Symptoms (SOPS) total scores [24 weeks]
Number of patients with specific adverse effects [24 weeks]
Change in social and role functioning scores [24 weeks]
Subjective well-being questionnaire [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

consent obtained from patients and their parents (assent for patients under 18);
age 12-25 years (inclusive);
English-speaking;
at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.

Exclusion Criteria:

lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
current stimulant treatment;
history of neurological, neuroendocrine or other medical condition known to affect the brain;
any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
past or current substance dependence; sunstance abuse within the last 4 weeks;
IQ < 70.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Zucker Hillside Hospital	Glen Oaks	New York	United States	11004

Sponsors and Collaborators

Northwell Health

Investigators

Principal Investigator: Christoph U Correll, MD, North Shore LIJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christoph U. Correll, MD, Professor of Psychiatry and Molecular Medicine Hofstra North Shore LIJ School of Medicine, Northwell Health

ClinicalTrials.gov Identifier:

NCT02357849

Other Study ID Numbers:

11-199

First Posted:

Feb 6, 2015

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022