Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Phase 4

Terminated

• Conditions: Attenuated Psychosis Syndrome
• Interventions: Drug: Aripiprazole; Drug: Fluoxetine

• Registration Number: NCT02357849
• Lead Sponsor: Northwell Health

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.

Detailed Description

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Status Verified: 2023-10
• Results First Submitted: 2023-10-05
• Results First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Results First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole	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).
Fluoxetine	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).

Primary Outcome Measures

Name	Time	Method
Time to Treatment Failure	24 weeks	Time to either all-cause-discontinuation or need to add another psychotropic agent

Secondary Outcome Measures

Name	Time	Method
Change in Prodromal Symptoms (SOPS) Total Scores	24 weeks	Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)
Change in Social and Role Functioning Scores	24 weeks	Change in social and role functioning scores (range: 0-10, higher sores = better outcome)
Number of Patients With Specific Adverse Effects	24 weeks	Number of patients with any adverse effects based on spontaneous report
Subjective Well-being Questionnaire	24 weeks	Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)

Trial Locations

Locations (1)

The Zucker Hillside Hospital; 🇺🇸 Glen Oaks, New York, United States