Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Attenuated Psychosis Syndrome Clinical Trial

— FACT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02357849
• Other study ID #: 11-199
• Status: Terminated
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: April 4, 2022

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attenuated Psychosis Syndrome
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Aripiprazole
see arm description
• Fluoxetine
see arm description

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Treatment Failure	Time to either all-cause-discontinuation or need to add another psychotropic agent	24 weeks
Secondary	Change in Prodromal Symptoms (SOPS) Total Scores	Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)	24 weeks
Secondary	Number of Patients With Specific Adverse Effects	Number of patients with any adverse effects based on spontaneous report	24 weeks
Secondary	Change in Social and Role Functioning Scores	Change in social and role functioning scores (range: 0-10, higher sores = better outcome)	24 weeks
Secondary	Subjective Well-being Questionnaire	Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)	24 weeks