Fluoxetine vs Aripiprazole Comparative Trial (FACT)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    48
  • sponsor
    Northwell Health
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Updated on 24 February 2021
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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

Details
Condition Attenuated Psychosis Syndrome
Treatment Aripiprazole, Fluoxetine
Clinical Study IdentifierNCT02357849
SponsorNorthwell Health
Last Modified on24 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 12 yrs and 25 yrs?
Gender: Male or Female
Do you have Attenuated Psychosis Syndrome?
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
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\
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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