Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Northwell Health

Status and phase: Terminated; Phase 4

Conditions: Attenuated Psychosis Syndrome

Treatments: Drug: Fluoxetine; Drug: Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02357849

11-199

Details and patient eligibility

About

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.

Full description

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

Enrollment: 9 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

9 participants in 2 patient groups

Aripiprazole

Active Comparator group

Description:

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).

Treatment:

Drug: Aripiprazole

Fluoxetine

Active Comparator group

Description:

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).

Treatment:

Drug: Fluoxetine