Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Phase 4TerminatedNCT02357849

Northwell Health9 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Attenuated Psychosis Syndrome

Interventions

AripiprazoleDRUG

see arm description

FluoxetineDRUG

see arm description

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Outcomes

Primary Outcomes

Time to Treatment Failure

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

Time frame: 24 weeks

Secondary Outcomes

Change in Prodromal Symptoms (SOPS) Total Scores

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

Time frame: 24 weeks

Number of Patients With Specific Adverse Effects

Number of patients with any adverse effects based on spontaneous report

Time frame: 24 weeks

Change in Social and Role Functioning Scores

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

Time frame: 24 weeks

Subjective Well-being Questionnaire

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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