Fluoxetine vs Aripiprazole Comparative Trial (FACT) (FACT)
Attenuated Psychosis Syndrome
About this trial
This is an interventional other trial for Attenuated Psychosis Syndrome
Eligibility Criteria
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.
Sites / Locations
- The Zucker Hillside Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Aripiprazole
Fluoxetine
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).
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).