The Role of Antidepressants or Antipsychotics in Preventing Psychosis

St. Luke's-Roosevelt Hospital Center

Overview

This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis. Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Psychotic Disorder

Interventions

AntidepressantDRUG

AntipsychoticDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 12-25 years of age (inclusive) * Able to understand and speak English * Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe Exclusion Criteria: * Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features * Current psychosis * Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features * Lifetime diagnosis of substance abuse or dependence (excluding nicotine) * Current stimulant treatment * Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain * Estimated intelligence quotient \< 70

Outcomes

Primary Outcomes

Attenuated positive, negative and general psychiatric symptoms

To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.

Time frame: 6 months

Secondary Outcomes

Social and role functioning

To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.

Time frame: 6 months

Time to all-cause discontinuation.

To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.

Time frame: 6 months

Adverse effects

To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.

Time frame: 6 months

Data from ClinicalTrials.gov

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