Fluoxetine vs Aripiprazole Comparative Trial (FACT) (FACT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Attenuated Psychosis Syndrome
• Intervention / Treatment: Drug: Aripiprazole; Drug: Fluoxetine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • The Zucker Hillside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Failure	Time to either all-cause-discontinuation or need to add another psychotropic agent	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Christoph U Correll, MD, North Shore LIJ

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimated): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Selective Serotonin Reuptake Inhibitors; Aripiprazole; Fluoxetine
• Other Study ID Numbers: 11-199